MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SHAFT FOR 90 SCREWDRIVER; DRILL, BONE, POWERED

Catalog Number 03.505.003

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2020

Event Type  malfunction  

Manufacturer Narrative

Additional procode: dzj.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020, the patient underwent ssro plate removal surgery.During the surgery, the surgeon assembled the shaft and handle and used them, but they were idling, and the surgeon couldn't turn a screw.The hospital had other devices and sterilized them and used them.The surgery was completed successfully with one hundred and twenty (120) minutes delay.Patient was stable following the procedure.This report is for a shaft for 90° screwdriver.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h4, h6: device history lot part number: 03.505.003, lot number: 8200812, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 07.July 2020.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Investigation summary: investigation site: cq zuchwil, selected flow: device interaction/functional.Visual inspection: the received shaft for screwdriver is visually in a good condition, there are just slight wear marks at the outside.The inner components with the gear wheels are in a very good condition with no visible damages.Functional testing: the shaft was for the visual inspection of the internal components disassembled and assembled without any issues during the test.Also it was possible to assemble and disassemble the shaft from the also received handle for screwdriver (03.505.004).The function test together with the handle has shown that the assembled devices do indeed idle or in other words when the hand piece at the handle is turned no torque is transferred to the coupling end of the shaft.The evaluation has shown that this issue is caused by the handle and not by the shaft.The shaft a stand alone device is functional as required, the torque is transferred to the coupling piece at the front end if the coupling at the end of the shaft is turned without the handle.Investigation conclusion: no functional issue at the received shaft for screwdriver could be detected, the evaluation has shown that the complained malfunction was caused by the also received handle.Therefore is this complaint rated as unconfirmed for the shaft as this device is functional as required.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.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.The root cause was identified during the performed cq evaluation and therefore the in the investigation flow listed remaining investigation steps are not required.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: SHAFT FOR 90 SCREWDRIVER
• Type of Device: DRILL, BONE, POWERED
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10602302
• MDR Text Key: 209198304
• Report Number: 8030965-2020-07522
• Device Sequence Number: 1
• Product Code: DZI
• UDI-Device Identifier: 07611819187474
• UDI-Public: (01)07611819187474
• Combination Product (y/n): N
• PMA/PMN Number: K082649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.505.003
• Device Lot Number: 8200812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Date Manufacturer Received: 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HAND; HANDLE; SHAFT; TURNING HANDLE; UNK - PLATES; UNK - PLATES; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA