MAUDE Adverse Event Report: SYNTHES GMBH INSERT-HANDLE RADIOLUC L100; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	03.010.486
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2022 while drilling a retrograde nail, part of the system and the jig used while hammering the nail came loose from the nail.At the end of the procedure, they realized that the tip of the jig where the nail attaches had broken off and the jig was able to stand with the screw still attached.The inserter jig broke off while inserting a nail.There was a 30 minute surgical delay to remove the fragment that broke off of the insertion handle.The procedure was completed successfully.This report is for a radiolucent insertion handle for expert nails/100mm.This is report 1 of 1 for (b)(4).
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.Device available for evaluation: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter is a synthes employee.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.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.Part: 03.010.486, lot : 8373324, release to warehouse date : 11.July.2013, manufacturing site: werk hagendrof.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from attachment.Visual analysis of the photo revealed that the insert-handle radioluc l100 had the tang/prong of the tip where it assembles to the notch of the nail broken, fragment is not visible in the evidence provided.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.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 the insert-handle radioluc l100.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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 was used for treatment, not diagnosis.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.Part: 03.010.486, lot : 8373324, release to warehouse date : 11.July.2013, expiration date : na, supplier: na, manufacturing site: werk hagendrof.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Note: dhr information was retrieved from pi-(b)(4) as it is the same lot number and same lot number name.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that insert-handle radioluc l100 had the prong of the tip broken.The broken fragment was not returned for examination.No other issues were found.A dimensional inspection for the insert-handle radioluc l100 was not performed as is not applicable to the complaint condition.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the insert-handle radioluc l100 would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.Drawing/specifications reviewed: the following source controlled drawings reflecting the current and manufactured revisions were reviewed: -insertion handle, radiolucent l manufactured.Dimensional inspection: n/a.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: INSERT-HANDLE RADIOLUC L100
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA ; 3035526892
• MDR Report Key: 16185847
• Report Number: 8030965-2023-00569
• Device Sequence Number: 14025719
• Product Code: LXH
• UDI-Device Identifier: 07611819498853
• UDI-Public: (01)07611819498853
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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 Model Number: 03.010.486
• Device Catalogue Number: 03.010.486
• Device Lot Number: 8373324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/20/2022
• Supplement Date Received by Manufacturer: 02/16/2023; 02/18/2023
• Initial Report FDA Received Date: 01/17/2023
• Supplement Report FDA Received Date: 02/17/2023; 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - NAILS: RFNA; UNK - SCREWS: TRAUMA
• Patient Sex: Male
• Patient Weight: 91 KG