MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINN CAN BONE SCREW 6.5MMX35MM; BONE SCREWS AND PINS : SCREWS

Catalog Number 121735500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Nerve Damage (1979); Hypoesthesia (2352); Ambulation Difficulties (2544); No Code Available (3191)

Event Date 01/19/2019

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.(b)(4).

Event Description

Subject id: (b)(6).Clinical adverse event received for femoral nerve palsy.Event is serious and is considered severe.Event has a remote possibility of being related to device and is probably related to procedure.Doi: (b)(6) 2019; doe: (b)(6) 2019, (right hip).Treatment includes emg and nerve conduction study.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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. .

• Brand Name: PINN CAN BONE SCREW 6.5MMX35MM
• Type of Device: BONE SCREWS AND PINS : SCREWS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8456153
• MDR Text Key: 140003123
• Report Number: 1818910-2019-88627
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295010388
• UDI-Public: 10603295010388
• Combination Product (y/n): N
• PMA/PMN Number: K983014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 121735500
• Device Lot Number: D18093275
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/07/2019
• Initial Date FDA Received: 03/27/2019
• Supplement Dates Manufacturer Received: 03/22/2019; 05/02/2019
• Supplement Dates FDA Received: 04/11/2019; 05/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 103