MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 3.5MM STARDRIVE CORTEX SCREW SELF-TAPPING 14MM; PLATE,FIXATION,BONE

Catalog Number 02.200.014TS

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2020

Event Type  malfunction  

Manufacturer Narrative

Additional product code: hwc.Reporter is jnj representative.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 that on an unknown date, the sterile tube did not open accordingly.It was unknown if the surgery completed successfully without delay.It was also unknown that if there any fragments generated.There were no patient consequences reported.This complaint involves eight (8) devices.This report is for (1) 3.5mm stardrive cortex screw self-tapping 14mm.This is report 2 of 8 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.H10 additional narrative: h3, h6: investigation summary.Investigation selection.Investigation site: (b)(4).Selected flow: packaging.Visual inspection: the screw was received with the reported condition that the inner tube did not disengage from outer tube.The inspection performed at cq zuchwil confirmed that after unscrewing the outer cap the entire inner tube (cap with holder and screw) is retained within the outer tube, preventing the screw from being removed and used.No further damage is visible.Summary: the complaint condition is confirmed as the inner tube is retained within the outer tube during disassembly preventing the screw from being removed and used.This production lot was manufactured in november 2019 according to the specification.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the inspection or release of the product 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.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 part: 02.200.014ts.Lot: 6l42856.Manufacturing site: (b)(4).Supplier: früh verpackungstechnik ag release to warehouse date: nov.18, 2019.Expiry date: nov.01, 2024.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: 3.5MM STARDRIVE CORTEX SCREW SELF-TAPPING 14MM
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10309302
• MDR Text Key: 199939170
• Report Number: 8030965-2020-05118
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07612334176073
• UDI-Public: (01)07612334176073
• 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
• Report Date: 07/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.200.014TS
• Device Lot Number: 6L42856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Date Manufacturer Received: 08/12/2020
• Patient Sequence Number: 1
• Treatment: CANCELLOUSSCR A; CANCELLOUSSCR A