MAUDE Adverse Event Report: DEPUY SPINE INC AEGIS ANTERIOR LUMBAR PLATE SCREWDRIVER, SELF-RETAINING

Model Number	287110180
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2022, during an unknown procedure, the instrument was discovered as defective.No further information was provided.This report is for one (1) aegis anterior lumbar plate screwdriver, self-retaining this is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Additional narrative: initial reporter is synthes sales representative the product was returned to us cq for evaluation.The us cq team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the tip of the aegis self-retain screwdrvr was stripped and twisted.The observed condition was consistent as an end of life indicator for the device.No other issues where identified.After a visual inspection per guidance provided in windchill document #(b)(4), 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.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 dull condition of the flutes of the aegis self-retain screwdrvr would have contributed to the complained device interaction issue.There is no indication that a design or manufacturing issue has caused the complaint condition.It was determined that the reusable instrument is worn from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.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 lot = > a review of the receiving inspection (ri) for self-retaining screw driver was conducted identifying that lot number mi78219 was released in a single batch.Batch1: lot qty of unit/s were released on 07apr2020 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.

• Brand Name: AEGIS ANTERIOR LUMBAR PLATE SCREWDRIVER, SELF-RETAINING
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 3035526892
• MDR Report Key: 13964804
• Report Number: 1526439-2022-00509
• Device Sequence Number: 4164100
• Product Code: HXX
• UDI-Device Identifier: 10705034218243
• UDI-Public: (01)10705034218243
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 287110180
• Device Catalogue Number: 287110180
• Device Lot Number: MI78219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2022
• Initial Report FDA Received Date: 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2020
• 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: AEGIS DRILL, FIXED
• Patient Sex: Unknown