MAUDE Adverse Event Report: SYNTHES GMBH PFNA 10 130 L240 TAN; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 472.265S

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/22/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.Reporter is a j&j sales representative.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.Investigation summary: the breakage of the nail could be confirmed according to the received pictures.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 history lot: part: 472.265s, lot: 81p0163.Manufacturing site: (b)(4), release to warehouse date: december 22, 2020, expiry date: december 01, 2030.A manufacturing record evaluation was performed for the finished device lot number, and no non conformance were identified.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 broken pfna nail.The pfna nail was implanted on unknown date of (b)(6) 2021 and broke on the (b)(6) 2021.The bottom part of the broken nail could not be removed during revision and remained in the patient.It was unknown if the revision surgery completed successfully.The patient outcome was unknown.Concomitant device reported: pfna blade perf l105 tan (part # 04.027.036s; lot # 79p9536; quantity: 1).Lockscr ø5 l36 f/nails tan light green (part # 04.005.526; lot # 54p0445; quantity: 1).This complaint involves one (1) device.This report is for (1) unk - plates.This report is 1 of 1 (b)(4).

• Brand Name: PFNA 10 130 L240 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11689184
• MDR Text Key: 247025870
• Report Number: 8030965-2021-03040
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819289239
• UDI-Public: (01)07611819289239
• 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
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 472.265S
• Device Lot Number: 81P0163
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 12/130 DEG TI CANN TFNA 235/LEFT - SILE; LOCKSCR Ø5 L36 F/NAILS TAN LIGHT GREEN
• Patient Outcome(s): Required Intervention