MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 3.5MM TI STARDRIVE CORTEX SCREW SELF-TAPPING 30MM; PLATE,FIXATION,BONE

Catalog Number 04.200.030TS

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Additional product code: hwc.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; 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: it was reported on an unknown date the inner part of the screw of the sterile-tube got stuck in the outer part.It was unknown the surgery was successfully completed, and any fragments was generated.There were no patient consequences.This complaint involves three (3) devices.This is report 1 of 3 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.H3, h6: the device has been received, the investigation is in progress, 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.

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.H3, h6: a product investigation was conducted.Visual inspection: the va locking screw was received with the reported condition that the inner tube did not disengage from outer tube.The visual inspection confirmed that the inner cap with holder and screw is retained within the outer tube during disassembly, which prevent the screw from being removed and used.No further damage is visible.Summary: the visual inspection confirmed that the inner cap with holder and screw is retained within the outer tube during disassembly, which prevent the screw from being removed and used.The manufacturing review shows that the production procedures were according to the specifications and there were no issues that would contribute to this complaint condition.Further investigation has shown that this production lot is part of the corrective and preventive action (capa) and part of the field safety notice fsn.The root cause was identified during the performed capa evaluation (inadequately defined design of the inner tube & inner cap).All further investigations and actions will be documented within capa and hence the in the investigation flow listed remaining investigation steps are not required.H3, h4, h6: a device history record (dhr) review was conducted: part: 04.200.030 , lot: 22p0614 , manufacturing site: balsthal , release to warehouse date: 24.Oct.2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Sterile-part part: 04.200.030ts, lot: 6l42375, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 18.Nov.2019, expiry date: 01.Nov.2024.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Non-sterile-part part: 04.200.030, lot: 22p0611, manufacturing site: balstahl, release to warehouse date: 28.Oct.2019.A manufacturing record evaluation was not performed since there is no allegation of the reported complaint condition.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: 3.5MM TI STARDRIVE CORTEX SCREW SELF-TAPPING 30MM
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10048340
• MDR Text Key: 191143256
• Report Number: 8030965-2020-03425
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K131186
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.200.030TS
• Device Lot Number: 6L42375
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2020
• Date Manufacturer Received: 06/25/2020
• Patient Sequence Number: 1
• Treatment: CORTSCR 3.5 SELF-TAP L30 TAN; CORTSCR 3.5 SELF-TAP L30 TAN; CORTSCR 3.5 SELF-TAP L30 TAN