MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC IMPACTOR

Catalog Number	391.919
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There is no patient involvement.It is unknown when device broke.Device is an instrument and is not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A device history record review has been requested.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 during cleaning, it was observed that the impactor¿s tip had broken off.There was no reported patient involvement.This report is for an impactor.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.A device history record (dhr) review was conducted for part number: 391.919, synthes lot number: p506464: supplier lot number: n/a, release to warehouse date: 04-oct-2001, expiration date: n/a, supplier: (b)(4): material review report (mrr) was generated during production for 20 parts with etch location on end of part, lock etch not on print, and knurl not depicted on print.Changes were made to source control print and design change order (dco) was created.Parts met specifications and were released.This non-conformance is not relevant to the complaint condition since it is not related to impactor items tip broken off.The material was reviewed, and the hardness value was confirmed to meet the specification with no (relevant) non-conformance noted.A product investigation was conducted.Service & repair evaluation: the customer reported the tip broke off the impactor.The repair technician reported the tip of the impactor was broken.Damaged component is the reason for repair.The cause of the issue is unknown.The following parts were replaced: tip for trd impactor.The item was repaired per the inspection sheet, passed synthes final inspection on 20-aug-2018 and will be returned to the customer upon completion of the service and repair process.The evaluation was confirmed.The device was deemed serviceable and returned to the customer.No design or manufacturing issues were identified; therefore, no corrective and/or preventative action is proposed.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
The issue was observed during cleaning on (b)(6) 2018.

• Brand Name: IMPACTOR
• Common Device Name: IMPACTOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7819024
• Report Number: 2939274-2018-53484
• Device Sequence Number: 19284671
• Product Code: HWA
• UDI-Device Identifier: 10886982198433
• UDI-Public: (01)10886982198433
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 08/08/2018

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 Catalogue Number: 391.919
• Device Lot Number: P506464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Initial Date Received by Manufacturer: 08/08/2018
• Supplement Date Received by Manufacturer: 08/30/2018
• Initial Report FDA Received Date: 08/27/2018
• Supplement Report FDA Received Date: 09/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1