MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: FNS; PLATE, FIXATION, BONE

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

Patient Problem Joint Dislocation (2374)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Date of event: event year is reported as 2021; however exact date of event is unknown.510k: this report is for an unk - plates: fns/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is jnj 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)(6) 2021, the patient underwent for a revision surgery due to the dislocation.On (b)(6) 2021 the patient underwent the implant surgery with the fns implants.After the surgery, the dislocation of the bone head was confirmed.The revision surgery was completed successfully with 60 minutes delay.The patient outcome was unknown.No further information is available.This complaint involves four (4) devices.This report is for (1) unk - plates: fns.This report is 1 of 4 for (b)(4).

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.H10 additional narrative: 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.

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.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: UNK - PLATES: FNS
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11488869
• MDR Text Key: 240309777
• Report Number: 8030965-2021-01978
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/17/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/17/2021
• Initial Date FDA Received: 03/15/2021
• Supplement Dates Manufacturer Received: 03/18/2021; 05/18/2021
• Supplement Dates FDA Received: 04/14/2021; 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Treatment: LOCKSCR Ø5 SELF-TAP L38 TAN; UNK - NAIL HEAD ELEMENTS: FNS ANTIROTATION; UNK - NAIL HEAD ELEMENTS: FNS BOLT
• Patient Outcome(s): Required Intervention
• Patient Age: 91 YR