MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC STARDRIVE SCREWDRIVER T25/SELF-RETAINING; SCREWDRIVERS

Model Number	03.010.107
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Complainant part is expected to be returned for manufacturer review /investigation but has yet to be received.Investigation summary: the device was not returned.A photo-investigation was performed on the image.The image was reviewed and the distal tip was observed to be stripped.No other issues were noted.No device identifiers were visible.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.Conclusion the complaint condition was confirmed during photo investigation, as the tip was observed to be stripped.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history lot: part # 03.010.107, lot # 9947380, manufacturing site: (b)(4), release to warehouse date: july 27, 2016.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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent for an intramedullary nail insertion surgery.During the surgery, it was noticed that the tips of the screwdrivers were rounded off.As well the rod pusher end appeared to have been broken off.The procedure was successfully completed without surgical delay.Patient consequence is unknown.This complaint involves eight (8) devices.This report is for (1) stardrive screwdriver t25/self-retaining.This report is 1 of 3 (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.H3, h4, h6- the complaint was confirmed during the investigation.After a visual inspection per guidance provided in windchill document, it is determined that the reusable instrument device is worn from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventative action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot = part # 03.010.107, lot # 9947380, manufacturing site: haegendorf, release to warehouse date: 27.July 2016.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.

• Brand Name: STARDRIVE SCREWDRIVER T25/SELF-RETAINING
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11809091
• Report Number: 2939274-2021-02327
• Device Sequence Number: 14322824
• Product Code: HXX
• UDI-Device Identifier: 10886982067791
• UDI-Public: (01)10886982067791
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2021

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: 03.010.107
• Device Catalogue Number: 03.010.107
• Device Lot Number: 9947380
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/15/2021
• Supplement Date Received by Manufacturer: 09/10/2021
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 10/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DCP HIPDRILLGUIDE 4.5 F/NEUTRAL+LOAD POS; DCP HIPDRILLGUIDE 4.5 F/NEUTRAL+LOAD POS; DCP HIPDRILLGUIDE 4.5 F/NEUTRAL+LOAD POS; DCP HIPDRILLGUIDE 4.5 F/NEUTRAL+LOAD POS; GRAPHIC CASE FOR ADOLESCENT LFN-EX INSTS; REAMING ROD PUSH ROD WITH BALL HANDLE; SD SCREWDRIVER T25/SELF-RETAINING/LONG