MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 42MM-STERILE; APPLIANCE, FIXATION, NAIL

Model Number	412.215S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Part: 412.215s, lot: 3l81996, manufacturing site: (b)(4), release to warehouse date: april 02, 2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.Customer quality investigation: the complaint device was not received for investigation.The following investigation is based on the image provided.The image was reviewed, and the complaint condition could be confirmed.From the provided x-rays, it can be seen that the two locking screws were broken.However, the device was not returned; dimensional inspection and a functional test were not able to be performed.A definitive assignable root cause could not be determined based on the provided information.During the investigation, no product design issues or discrepancies were observed (that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.(b)(4).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.
Event or Problem Description
It was reported that the patient underwent removal surgery on (b)(6) 2020, due to non-union and breakage of two (2) locking screws.The procedure was completed successfully.Concomitant devices: bolt for femoral neck system (part: 04.168.295s, lot: 3l42036, quantity: 1) antirotation screw (part: 04.168.500s-us, lot: l874140, quantity: 1), femoral neck system plate (part: 04.268.000s, lot: 3l42036, quantity: 1), 5.0mm locking screw 42mm (part: 412.215s, lot: unknown, quantity: 1).This report is for a 5.0mm titanium (ti) locking screw 42mm.This is report 1 of 2 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.The complaint device was not received for investigation.The following investigation is based on the image provided the image was reviewed, and the complaint condition could be confirmed.From the provided x-rays, it can be seen that the two locking screws were broken.However, the device was not returned, dimensional inspection and a functional test were not able to be performed.A definitive assignable root cause could not be determined based on the provided information.During the investigation, no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot part: 412.215s, lot: 3l81996, manufacturing site: mezzovico release to warehouse date: 02.April 2019, expiration date: 01.March 2029.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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
Product complaint # (b)(4).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 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: 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 42MM-STERILE
• Common Device Name: APPLIANCE, FIXATION, NAIL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9792608
• Report Number: 2939274-2020-01132
• Device Sequence Number: 11406593
• Product Code: KTT
• UDI-Device Identifier: 10886982275424
• UDI-Public: (01)10886982275424
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K000682
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 412.215S
• Device Catalogue Number: 412.215S
• Device Lot Number: 3L81996
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/07/2020
• Supplement Date Received by Manufacturer: 03/04/2020; 04/02/2020
• Initial Report FDA Received Date: 03/05/2020
• Supplement Report FDA Received Date: 03/30/2020; 04/03/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5.0MM TI LOCKING SCREW; ANTIROTATION SCREW FOR FEMORAL NECK SYSTEM; BOLT FOR FEMORAL NECK SYSTEM; FEMORAL NECK SYSTEM PLATE
• Outcome Attributed to Adverse Event: Required Intervention