MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 1.5MM TI VA-LCKNG SCR SLF-TPNG WITH T4 STARDRIVE RECESS 12MM; SCREW, FIXATION, BONE

Catalog Number 04.130.212S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 05/17/2018

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: additional procode: hrs.Device has not been explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Part: 04.130.212s; lot: 9858773; manufacturing location: (b)(4); release to warehouse date: march 16, 2016; expiry date: march 01, 2026; no nonconformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(b)(4).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 europe reports an event in (b)(6) as follows: it was reported that the va-hand system was applied to hand fractures on (b)(6) 2018.During insertion of the va locking screw in question, its screw head was stripped.As it became difficult to remove the screw, the surgeon left it as it was.The surgery was completed successfully with a thirty (30) minute delay.There was no adverse consequence to the patient.This report is for a 1.5mm ti va-lckng scr slf-tpng with t4 stardrive recess 12mm.(b)(4).

• Brand Name: 1.5MM TI VA-LCKNG SCR SLF-TPNG WITH T4 STARDRIVE RECESS 12MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK GRENCHEN (CH); solothurnstrasse 186; grenchen 2540 ; SZ 2540
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7586187
• MDR Text Key: 110584408
• Report Number: 8030965-2018-54232
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07612334092274
• UDI-Public: (01)07612334092274
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K141527
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.130.212S
• Device Lot Number: 9858773
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2018
• Date Device Manufactured: 03/16/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1