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

Model Number 338.28

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hematoma (1884)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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 Description

It was reported that on (b)(6) 2020, during a hip surgery, a piece of a broken dynamic hip system (dhs) screw was found.The surgeon did the case to wash out a hip that had a hematoma.Initially, the patient had a facility dynamic hip screw put in on an unknown date.When the surgeon washed the hip out, a piece of something came out.It appears a small piece of the impactor for the dynamic hip system (dhs) had broken off when the initial surgery occurred.Fragments were generated and were removed easily without additional intervention.The procedure was successfully completed with no surgical delay.No patient consequence.This complaint involves one (1) device.This report is for (1) dhs®/dcs® impactor.This report is 1 of 1 for (b)(4).

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.H11 corrected data: b3: date of event is an unknown date in 2020.D6: date of implant is not relevant as device in question is not an implantable device.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: DHS/DCS IMPACTOR
• Type of Device: IMPACTOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11132729
• MDR Text Key: 225577105
• Report Number: 2939274-2021-00073
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 10886982193308
• UDI-Public: (01)10886982193308
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 338.28
• Device Catalogue Number: 338.28
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention