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

Catalog Number 472.101S

Device Problem Device Handling Problem (3265)

Patient Problem No Code Available (3191)

Event Date 12/03/2019

Event Type  Injury  

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). The patient will be under no weight bearing). Investigation summary 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. A review of the device history record. Device history lot: part: 472. 101s. Lot: 5l16200. Manufacturing site: (b)(4). Release to warehouse date: 11. July 2019. Expiry date: 01. July 2029. 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) 2019, the patient underwent an open reduction internal fixation surgery for the femoral trochanteric fracture with the pfna in question. Before the surgery, there was no problem with the devices when the hospital checked them. During the surgery when the surgeon was inserting the blade, he felt a resistance. He tried to remove it, but the blade could not be removed at all. The surgeon used an extraction screw and a hammer, but the blade could not be extracted. The surgeon used headless compression screw 4. 5/6. 5 for additional fixation. The patient will be under no weight bearing. The hospital plans a reoperation to remove or to cut the blade. No further information is available. Concomitant devices reported: unknown impaction instruments: hammer/mallet: trauma (part#: unknown, lot#: unknown, quantity#: 1) unknown extraction instruments: tfna/pfna (part#: unknown, lot#: unknown, quantity#: 1). This complaint involves two (2) devices. This report is for one (1) pfna-ii ø10 xs 125° l170 tan. This report is 1 of 2 for (b)(4).

• Brand Name: PFNA-II Ø10 XS 125° L170 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kara ditty-bovard ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 6103142063
• MDR Report Key: 9507695
• MDR Text Key: 188241220
• Report Number: 8030965-2019-71343
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 472.101S
• Device Lot Number: 5L16200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2019
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 12/20/2019 Patient Sequence Number: 1