MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM FLEXIBLE SHAFT; REAMER

Catalog Number 352.040

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/14/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.Occupation: reporter is a j&j representative.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.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

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(4) 2021, the patient underwent for a procedure.During the procedure, the flexible reaming rod was not self-retaining the reaming tips.There was no fragment generated.The procedure was completed successfully.The patient outcome was unknown.Concomitant device reported: unknown reduction head (part#: unknown, lot#: unknown, quantity: 1).This complaint involves two (2) devices.This report is for (1) 5.0mm flexible shaft.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.H10 additional narrative: d7a.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: 5.0MM FLEXIBLE SHAFT
• Type of Device: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12318560
• MDR Text Key: 266401834
• Report Number: 2939274-2021-04650
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 07611819243668
• UDI-Public: (01)07611819243668
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 07/15/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 352.040
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/15/2021
• Initial Date FDA Received: 08/13/2021
• Supplement Dates Manufacturer Received: 09/16/2021
• Supplement Dates FDA Received: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1