MAUDE Adverse Event Report: DEPUY SPINE INC STANDARD SCREWDRIVER; SCREWDRIVERS

Model Number	286509000
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Additional narrative: reporter is a j&j sales representative.Investigation summary investigation flow: damage visual inspection: the standard screwdriver (p/n:286509000, lot #: gm3521101) was returned and received at us cq.Upon visual inspection, it was observed that the tip of the driver was stripped and twisted.The stripped/worn condition of the distal tip is consistent as an end of life indicator for the device.No other issues were identified during inspection.The received condition is consistent with the complaint condition thus the complaint was confirmed.Conclusion: after a visual inspection per guidance provided in windchill document # 0000277191, it is determined that the reusable instrument 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 preventive 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 a review of the receiving inspection (ri) for standard screwdriver was conducted identifying that lot number gm3521101 was released in a single batch.Batch1: lot qty of 24 units were released on (b)(6) 2012 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Device history review the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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 canada as follows: it was reported that on an unknown date the standard screwdriver was damaged.It was unknown how it occurred.There was no procedure and patient involvements are reported.This complaint involves one (1) device.This report is for (1) standard screwdriver.This report is 1 of 1(b)(4).

• Brand Name: STANDARD SCREWDRIVER
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11653238
• Report Number: 1526439-2021-00699
• Device Sequence Number: 14326884
• Product Code: HXX
• UDI-Device Identifier: 10705034212784
• UDI-Public: 10705034212784
• 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
• Report Date (Section B): 03/15/2021

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: 286509000
• Device Catalogue Number: 286509000
• Device Lot Number: GM3521101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 04/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1