MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH CORTSCR A~¸3.5 SELF-TAP L26 TAN; PLATE,FIXATION,BONE

Catalog Number 04.200.026TS

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Additional product code: hwc.The device was 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 on an unknown date that the inner part with the screw of the sterile tube got stuck in the outer part.There was no medical procedure or delay reported.There was no patient consequence.This complaint involves eleven (11) devices.This is 2 of 9 for report (b)(4).Related product complaint: (b)(4).

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.H3, h4, h6: the part was received in an already opened condition.Otherwise, the part is in a good condition.Furthermore, there are no signs of a foreign substance.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.Device history lot sterile part: 04.200.026ts.Lot: 6l12153 manufacturing site: selzach.Supplier: (b)(4).Release to warehouse date: 25.Sep.2019.Expiry date: 01.Sep.2024.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.Non-sterile part: 04.200.026.Lot: 5l86881.Manufacturing site: balsthal.Release to warehouse date: 04 sep 2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's 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.

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.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: CORTSCR A~¸3.5 SELF-TAP L26 TAN
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9878427
• MDR Text Key: 190327723
• Report Number: 8030965-2020-02268
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819300507
• UDI-Public: (01)07611819300507
• 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: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.200.026TS
• Device Lot Number: 6L12153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2020
• Date Manufacturer Received: 04/16/2020
• Patient Sequence Number: 1
• Treatment: CANCELLOUSSCR Ø4 L50/15 SST; CANCELLOUSSCR Ø4 L50/15 TI; CORTSCR 3.5 SELF-TAP L26 TAN; CORTSCR 3.5 SELF-TAP L26 TAN; CORTSCR 3.5 SELF-TAP L30 TAN; CORTSCR 3.5 SELF-TAP L40 TAN; LOCKSCR Ø3.5 SELF-TAP L38 TAN; LOCKSCR Ø3.5 SELF-TAP L44 TAN; LOCKSCR Ø3.5 SELF-TAP L50 TAN; LOCKSCR Ø3.5 SELF-TAP L50 TAN; LOCKSCR Ø3.5 SELF-TAP L50 TAN