MAUDE Adverse Event Report: SYNTHES GMBH PFNA-II Ø10 130° L240 TAN ROD, FIXATION, INTRAMEDULLARY

Catalog Number 473.805S

Device Problem Material Deformation (2976)

Patient Problems Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/07/2022

Event Type  Injury  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that a device deformed post-op. This case is from health authority. It was reported that the patient was hospitalized with femoral fracture, and then underwent operation. The intramedullary device was implanted during the operation. Recently, he was hospitalized due to the problem of internal fixation device. After film examination, it was found that the device intramedullary was bent and could not achieve the effect of support. The patient underwent secondary surgery. No additional information can be provided. This complaint involves one (1) device pfna-ii ø10 130° l240 tan. This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Product complaint # (b)(4). Complainant part is not expected to be returned for manufacturer review/investigation. Device is not distributed in the united states but is similar to device marketed in the usa. (b)(4). A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified. 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.

• Brand Name: PFNA-II Ø10 130° L240 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 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14134670
• MDR Text Key: 289427234
• Report Number: 8030965-2022-02485
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 473.805S
• Device Lot Number: 4L10277
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 04/11/2019
• Is the Device Single Use?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 04/18/2022 Patient Sequence Number: 1