MAUDE Adverse Event Report: SYNTHES GMBH SCFE SCR ø7.3 CANN L90/20; SCREW, FIXATION, BONE

Catalog Number	02.207.627S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on an unknown date in (b)(6) 2024, the patient was being surgically operated on with a screw, and the screw was broken at the tread.The healthcare provider asked how to remove the screw and the thread.The event was reported to have occurred post-implant.No further details were provided.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: d4: udi: as the catalog/model number was not provided, the (01)gtin is not available.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned photo.Visual analysis of the photo revealed that unk - screws: cmf was observed broken at the first thread, both fragments were observed in the visual evidence provided.No other issues were identified.With the information provided is not possible to determine a potential cause at this moment.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for unk - screws: cmf.There is no indication that a design or manufacturing issue has caused the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.The device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Additional information received states that due to screw breakage, the instability of the epiphysiolysis capitis femoris on the left required partial removal of the broken screw and refixation using k-wires by means of a surgical procedure.The reason for removal/revision surgery was a screw fracture on the left.The growth plate was not yet closed and further stabilization was required.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h4, h6: the photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned photo from attachmen.Visual analysis of the photo revealed that scfe scr ã¸7.3 cann l90/20 was observed broken at the first thread, both fragments were observed in the visual evidence provided.No other issues were identified.With the information provided is not possible to determine a potential cause at this moment.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for scfe scr ã¸7.3 cann l90/20.There is no indication that a design or manufacturing issue has caused the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review : part # 02.207.627s, lot # 5l23759, manufacturing site: früh verpackungstechnik ag, release to warehouse date: 26 jun 2019, expiration date: 01 jun 2029, supplier: (b)(4).Non-sterile part # 02.207.627 non-sterile lot # h492322 manufacturing site:, werk selzach logistik release to warehouse date: 09 oct 2017 supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h4, h6: the product was returned to j&j medtech orthopaedics for evaluation.The j&j medtech orthopaedics team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that scfe scr ã¸7.3 cann l90/20 was observed broken at the first thread, fragments were not returned.No other issues were identified.With the information provided is not possible to determine a potential cause at this moment.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.A dimensional inspection was not performed due to the post-manufacturing damage.The overall complaint was confirmed as the observed condition of the scfe scr ã¸7.3 cann l90/20 would contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Device history review : part # 02.207.627s, lot # 5l23759, manufacturing site: früh verpackungstechnik ag, release to warehouse date: 26 jun 2019, expiration date: 01 jun 2029, supplier: (b)(4).Non-sterile part # 02.207.627 non-sterile lot # h492322 manufacturing site:, werk selzach logistik release to warehouse date: 09 oct 2017 supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: SCFE SCR ø7.3 CANN L90/20
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach CO ; SZ
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 20170370
• Report Number: 8030965-2024-10961
• Device Sequence Number: 7113431
• Product Code: HWC
• UDI-Device Identifier: 10886982052568
• UDI-Public: (01)10886982052568(17)290601(10)H492322
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 02.207.627S
• Device Lot Number: H492322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2024
• Supplement Date Received by Manufacturer: 09/18/2024; 10/22/2024; 10/25/2024
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 09/26/2024; 10/23/2024; 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown