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

Model Number	338.26
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event date is unknown date in 2022.Initial reporter is j&j company representative.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that tip for dhs/dcs impactor (338.28) was observed that the handle was broken and the broken part was not returned.There were scratches on the device but have no impact on the device functionality.No other issues were identified with the returned device.A dimensional inspection for the tip for dhs/dcs impactor (338.28) was unable to be performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces as mentioned in the event description.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 condition of the tip for dhs/dcs impactor (338.28) would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.Drawing/specifications reviewed: no issues with drawings dimensional inspection: n/a.It was reported that dhs impactor has been damaged throughout years of use.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from attachment.Visual analysis of the photo revealed that ins f/dhs/dcs impactor no.338.280 was deformed and scratched due to use.The overall complaint was confirmed for ins f/dhs/dcs impactor no.338.280.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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: part# 338.26, synthes lot# h786340, supplier lot# h786340, release to warehouse date: 15 oct2019, supplier: avalign techologies-nemcomed.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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 (b)(6) as follows: it was reported a dynamic hip screw (dhs) system impactor was noted as damaged in a dhs set.The device has been damaged throughout years of use.No patient involvement.This is report 1 of 1 for (b)(4).This report is for a dhs impactor.

• 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
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14166977
• Report Number: 2939274-2022-01412
• Device Sequence Number: 4988414
• Product Code: HWA
• UDI-Device Identifier: 10886982193292
• UDI-Public: (01)10886982193292
• 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: 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: 338.26
• Device Catalogue Number: 338.26
• Device Lot Number: H786340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2022
• Initial Report FDA Received Date: 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown