MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 5.0MM LOCKING SCREW SLF-TPNG WITH T25 STARDRIVE RECESS 36MM; SCREW, FIXATION, BONE

Model Number	212.212
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: additional product codes: ktt, hrs.(b)(6).: part 212.212, lot 9675107: manufacturing site: mezzovico.Release to warehouse date: october 09, 2015.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.A product investigation was completed: the screw was received with portions of the threads on the shaft stripped.No other issues were identified with the returned screw.Dimensional inspection showed the relevant dimensions were conforming.The relevant drawings, reflecting the manufactured and current revision, were reviewed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.No definitive root cause could be determined.It is possible that stripped condition was due to excessive forces/torque applied during insertion or extraction.During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date, a revision surgery was scheduled due to a possible refracture and or non-union.The construct originally implanted was implanted off-label.The revision surgery was scheduled for (b)(6) 2019 and will be performed by another surgeon.Original implant date was on (b)(6) 2019.It is unknown if the re-scheduled surgery has occurred.During investigation of the returned devices it was noted that portions of the threads on the shaft of the screw were stripped.Concomitant devices: cortex screw (part 214.838, lot 9202997, 9271477, l888929, quantity 3); cortex screw (part 214.840, lot l663008, quantity 1); locking screw (part 212.212, lot 9201970, quantity 1); screw (part/lot unknown, quantity 1).The linked event is captured in (b)(4).This report is for a locking screw.This is report 3 of 4 for (b)(4).

• Brand Name: 5.0MM LOCKING SCREW SLF-TPNG WITH T25 STARDRIVE RECESS 36MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9181144
• Report Number: 8030965-2019-69272
• Device Sequence Number: 2830743
• Product Code: HWC
• UDI-Device Identifier: 10886982152190
• UDI-Public: (01)10886982152190
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K000682
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/26/2019

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
• Operator of Device: Health Professional
• Device Model Number: 212.212
• Device Catalogue Number: 212.212
• Device Lot Number: 9675107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/02/2019
• Initial Report FDA Received Date: 10/11/2019
• Patient Sequence Number: 1