MAUDE Adverse Event Report: SYNTHES GMBH PFNA-II Ø10 XS 125° L170 TAN; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 472.101S

Device Problem Migration (4003)

Patient Problems Bone Fracture(s) (1870); Pain (1994)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter occupation: reporter is a j&j sales representative.Device is not distributed in the united states, but is similar to device marketed in the usa.Device evaluated by mfr and manufacture date: a device history record (dhr) review was conducted: part # 472.101s, lot # 64p5091, manufacturing site: (b)(4), release to warehouse date: (b)(6) 2020, expiry date: 01.August.2030, a manufacturing record evaluation was performed for the finished device lot and no non-conformance was identified.Device evaluated by mfr: the investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or 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 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 depuy synthes reports an event in japan as follows: it was reported that on (b)(6) 2021, the patient underwent a surgery with the proximal femoral nail anti-rotation (pfna) system.The surgery was completed successfully without any surgical delay.The patient had been doing well since the surgery; however, patient fell down on (b)(6) 2022.The patient went to the hospital and complained of pain on (b)(6) 2022.It was confirmed that proximal cut-out and a secondary fracture at the distal nail occurred.The revision surgery was performed on (b)(6) 2022.No further information is available.This report is for one (1) pfna-ii ø10 xs 125° l170 tan.This is report 2 of 2 for complaint (b)(4).

• Brand Name: PFNA-II Ø10 XS 125° L170 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 14630035
• MDR Text Key: 293527500
• Report Number: 8030965-2022-03761
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819837263
• UDI-Public: (01)07611819837263
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 472.101S
• Device Lot Number: 64P5091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: PFNA-II BLADE L80 TAN
• Patient Outcome(s): Required Intervention
• Patient Age: 91 YR
• Patient Sex: Female