MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LCP® DHHS(TM) IMPACTOR CAP; GUIDE

Model Number	338.348
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 on (b)(6) 2019, the locking compression plate (lcp) dhhs impactor cap was broken during the case.Fragments were generated but easily removed.There was no surgical delay.Procedure and patient outcome were unknown.This report is for an impactor cap.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 history records review was completed for part: 338.348, lot: 4708049.Manufacturing location: brandywine, release to warehouse date: apr 04, 2004.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The raw material was confirmed to be correct per the specification with no relevant non-conformance noted.Product investigation was completed.The lcp dhhs impactor cap was received.The bottom of the impactor cap has a hole in it that does not go through to the other side, but does reach the internal space of the impactor cap.Some of the material is missing around the hole.The missing fragment of material was not returned.No other issues could be identified with the returned portions of the device.A dimensional inspection was not performed due to post-manufacturing damage.Relevant drawings were reviewed.The complaint is confirmed for the lcp dhhs impactor cap.There is a chunk of material missing from the bottom of the impactor cap, exposing the inner hollow space of the impactor cap.No other issues could be identified with the device.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined, it is possible that the device encountered unintended forces.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.

• Brand Name: LCP® DHHS(TM) IMPACTOR CAP
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8617009
• Report Number: 2939274-2019-58119
• Device Sequence Number: 2372455
• Product Code: FZX
• UDI-Device Identifier: 10886982193438
• UDI-Public: (01)10886982193438
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2019

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: 338.348
• Device Catalogue Number: 338.348
• Device Lot Number: 4708049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2019
• Initial Date Received by Manufacturer: 04/17/2019
• Supplement Date Received by Manufacturer: 05/31/2019
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 05/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 41 YR