MAUDE Adverse Event Report: SYNTHES GMBH PFNA-II Ø11 SM 130° L200 TAN ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 472.116S

Device Problem Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/29/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4). Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received. Note: description updated to remove dr. Brian coutiho & "kindly note the complaint is raised late since i had a family medical emergency from (b)(6). " the investigation could not be completed, no conclusion could be drawn at the time of filing this report. 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. 116s, lot: 68p6342, manufacturing site: (b)(4). Release to warehouse date: september 28, 2020. Release to warehouse date: september 01, 2030. A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances 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 fracture nailing surgery. During the surgery, while inserting the blade through the nail, the blade wasn't going through. He was unable to insert the nail. The surgery was delayed five minutes. The surgery was completed successfully. There were no patient consequences are reported. Concomitant device reported: unknown pfna ii blade (part# unknown; lot# unknown; quantity: 1). This complaint involves one (1) device. This report is for (1) pfna-ii ø11 sm 130° l200 tan. This report is 1 of 1 (b)(4).

• Brand Name: PFNA-II Ø11 SM 130° L200 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11720371
• MDR Text Key: 249798180
• Report Number: 8030965-2021-03239
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2021
• 2 Devices were Involved in the Event: 1 2

0 Patients were Involved in the Event:

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 472.116S
• Device Lot Number: 68P6342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown