MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH DHS®/DCS® LAG SCREW 12.7MM THREAD/95MM; APPLIANCE,FIXATION,NAIL

Catalog Number 280.950S

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/04/2019

Event Type  malfunction  

Manufacturer Narrative

Complainant part returned.Synthes sales representative.A review of the device history record has been requested.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.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: assorted coordinator medical devices: alexander schalk: dhs plate did not fit over the dhs screw during insertion.After removal it was tested on the sterile table, several persons tried to put the screw into the plate but were unsuccessful.Unpacked a second screw, tested it on the sterile table and was able to pass the plate.Concomitant device reported: unk - plates: dhs/dcs (part # unknown, lot # unknown, quantity # 1).This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

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.The dhs/dcs® screw was received with the reported condition of not functioning.The visual inspection has shown that the positioning groove of the dhs/dcs® screw is expanded and damaged.The investigation of the dhs/dcs screw has shown that the positioning groove of the screw is damaged and widened up, this damage prevents the insertion of the plate.The review of the production history revealed that this implant was manufactured in january 2019 according to the specifications.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities reported.The relevant dimensions at the undamaged area were checked, and no deviation was detected.The damage occurred is determined to be post-manufacturing.The type and extent of damage incurred indicates that the positioning groove has been widened up due to inadequate handling.In order to ensure a correct load transfer it is crucial to have an appropriate connection between the dhs-screw and the connecting screw 338.310, which is guided through the appropriate dhs/dcs wrench.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot part: 280.950s, lot: 3l07321, manufacturing site: balsthal, release to warehouse date: 28 jan 2019, expiry date: 01 jan 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.

• Brand Name: DHS®/DCS® LAG SCREW 12.7MM THREAD/95MM
• Type of Device: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8852182
• MDR Text Key: 153246439
• Report Number: 8030965-2019-66748
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07611819055469
• UDI-Public: (01)07611819055469
• Combination Product (y/n): N
• PMA/PMN Number: K791619
• 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: 07/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 280.950S
• Device Lot Number: 3L07321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Date Manufacturer Received: 08/20/2019
• Patient Sequence Number: 1