MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH EXTRACTION SCREW FOR TI FEMORAL AND TIBIAL NAILS; EXTRACTOR

Catalog Number 357.133

Device Problems Dull, Blunt (2407); Naturally Worn (2988)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record: device history lot: part: 357.133.Lot: 1l59077.Manufacturing site: (b)(6).Release to warehouse date: 22.October 2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Investigation summary investigation selection: investigation site: (b)(6).Selected flow: damage.Visual inspection: the returned device was examined and was found the distal tip was found to be stripped.Furthermore there are heavy hammer marks visible on the entire device's surface.Investigation summary: our investigation has shown that the complaint condition for the received device is confirmed due to the damage.After a visual inspection, it is determined that the reusable instrument is worn from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.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 an unknown date, during removal of an unknown expert tibial nail (etn), the threads of the extraction screw and the conducting rod were noted to be defective.It is unknown if there was surgical delay.Procedure outcome and patient status are unknown.Concomitant device reported: unknown expert tibial nail (etn) (part# unknown, lot# unknown, quantity 1).This complaint involves one (1) devices.This report is 1 of 1 for (b)(4).

• Brand Name: EXTRACTION SCREW FOR TI FEMORAL AND TIBIAL NAILS
• Type of Device: EXTRACTOR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 6103142063
• MDR Report Key: 8885168
• MDR Text Key: 154104559
• Report Number: 8030965-2019-67135
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 07611819144163
• UDI-Public: (01)07611819144163
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 357.133
• Device Lot Number: 1L59077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2019
• Initial Date FDA Received: 08/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2018
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1