MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TIP FOR DHS®/DCS® IMPACTOR (338.28)

Model Number	338.26
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a synthes employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 an unknown date, the tip for dynamic hip and condylar screw system (dhs/dcs) impactor broke.The issue was found out in the sterile processing department.There was no patient involvement.This complaint involves one (1) device.This is 1 of 1 for report (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: the device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.The incorrect date rec'd by mfr was inadvertently utilized in initial medwatch.The correct date is november 11, 2019.  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.
Additional Manufacturer Narrative
Product complaint # (b)(4).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: a review of the device history record.Device history lot part number: 338.26, synthes lot number: 4152314 , supplier lot number: n/a, release to warehouse date: 24 nov 2000, expiration date: n/a, manufactured by synthes brandywine.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.H3, h6: investigation summary background: it was reported that on an unknown date, the tip for dynamic hip and condylar screw system (dhs/dcs) impactor broke.The issue was found out in the sterile processing department.There was no patient involvement.This complaint involves one (1) device.S&r evaluation: the customer reported the tip for dynamic hip and condylar screw system (dhs/dcs) impactor broke.The repair technician reported the tip was broken.Tip broken is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.Investigation flow: damage.Visual inspection: tip for dhs®/dcs® impactor (338.28) was received at us cq.Upon visual inspection at cq, it is observed that the tip part of the device got broken.The rest of the device shows normal wear which would not contribute to the complaint condition.Thus, the complaint is being confirmed.Dimensional inspection: dimensional inspection of the received device was not performed at cq due to post manufacturing damage.Documentation/ specification review: the following drawing(s) was reviewed; tip for dhs/ dcs impactor: 338_26_1 rev.A and rev.D tip for dhs/ dcs impactor pinned assembly: 338_26 rev.C and rev.H no design issues or discrepancies were found during this investigation.Investigation conclusion: visual inspection, and document specification review of the received device was performed at cq.The complaint is being confirmed as it is observed that the tip part of the device got broken.While a definitive root cause could not be determined, it is possible that the device might have encountered unintended forces.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.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.H11: per reporter the correct awareness date is: nov.11, 2019.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.
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.H11: corrected data: g4: awareness date reported on follow up 2 report as december 04, 2019 but should have been december 30, 2019.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: TIP FOR DHS®/DCS® IMPACTOR (338.28)
• Common Device Name: IMPACTOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9401873
• Report Number: 2939274-2019-62432
• Device Sequence Number: 2089844
• Product Code: HWA
• UDI-Device Identifier: 10886982193292
• UDI-Public: (01)10886982193292
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/11/2019

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: 338.26
• Device Catalogue Number: 338.26
• Device Lot Number: 4152314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Initial Date Received by Manufacturer: 11/12/2019
• Supplement Date Received by Manufacturer: 12/04/2019; 12/04/2019; 01/07/2020
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 12/23/2019; 01/06/2020; 01/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1