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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.A dhr file for part #338.26, lot #440012 combination could not be found in the synthes systems.If more information becomes available this dhr review will be revisited.Product was not returned.Based on the information available, it has been determined that no corrective and 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 (b)(6) 2021, while inserting a dynamic hip system (dhs) plate with the impactor, the plastic portion of the impactor broke.The pieces were retrieved successfully, and the surgery was successfully completed.There was no patient harm or surgery delay.This report involves one (1) ti tip for dhs®/dcs® impactor (338.28).This is report 1 of 1 for (b)(4).

• 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: 11258588
• Report Number: 2939274-2021-00588
• Device Sequence Number: 3692140
• Product Code: HWA
• UDI-Device Identifier: 10886982193292
• UDI-Public: (01)10886982193292
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/12/2021

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: 440012
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 02/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 121