MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 3.5MM TI STARDRIVE CORTEX SCREW SELF-TAPPING 28MM; PLATE,FIXATION,BONE

Catalog Number 04.200.028TS

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, that the inner part with the screw of the sterile-tube became stuck in the outer part.The event occurred pre-op.There are no consequences to the patient, the patient was under anesthesia.This report involves one (1) 3.5mm ti stardrive cortex screw self-tapping 28mm.This is report 4 of 7 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.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

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: a review of the device history record.Device history lot dhr for sterile product: part: 04.200.028ts , lot: 6l37455, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 05.Nov.2019, expiry date: 01.Oct.2024.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Non sterile: part: 04.200.028 , lot: 6l26918 , manufacturing site: balsthal , release to warehouse date: 14 october 2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances related to the malfunction were identified.Planned non-product non-conformity #nr-0132743 was opened to manage all work orders (wo) and purchase orders (po) which were in wip during the cutover phase from old erp (sap p01) to new erp (sap p02).This nc is affecting dhr reconciliation only and, for this reason, products are not impacted.H3, h6: investigation summary: the device was forwarded to the packaging development engineer for further investigation.The final conclusion has shown that the affected lots and failure modes occurred are covered by the field safety notification, hence not further steps are required.Investigation selection investigation site: cq zuchwil, selected flow: packaging.Visual inspection: the parts were received in an opened condition within the corresponding original sterile tubes.All features related to the reported complaint condition were reviewed and no other issues were identified.Summary: further investigation has shown that this production lot root cause was identified during the performed evaluation.All further investigations and actions will be documented within and 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: 3.5MM TI STARDRIVE CORTEX SCREW SELF-TAPPING 28MM
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9917168
• MDR Text Key: 187191239
• Report Number: 8030965-2020-02565
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819300514
• UDI-Public: (01)07611819300514
• 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: 03/06/2020

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: 04.200.028TS
• Device Lot Number: 6L37455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Initial Date Manufacturer Received: 03/06/2020
• Initial Date FDA Received: 04/02/2020
• Supplement Dates Manufacturer Received: 05/07/2020; 05/15/2020
• Supplement Dates FDA Received: 05/18/2020; 05/20/2020
• Patient Sequence Number: 1
• Treatment: LOCKSCR Ø3.5 SELF-TAP L36 TAN