MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 4U I/C; SCREW, FIXATION, BONE

Catalog Number 04.503.104.04S

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2019

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Investigation summary: 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.Device history lot: part: 04.503.104.04s, lot: 3l80064, manufacturing site: (b)(4), release to warehouse date: 19.Mar.2019, expiry date: 01.Mar.2029.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.(b)(4).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 it was recognized at the time of skull closure during the surgery on (b)(6) 2019 that there were only 3 screws in the package instead of 4.The surgery was completed by using an additional screw.There was no surgical delay and there was no harm to the patient.No further information is available.Concomitant device reported: matrixneuro screws (part # 04.503.104.04s, lot # unknown, quantity 3), unknown matrixneuro plate (part # unknown, lot # unknown, quantity unknown).This complaint involves one (1) device.This is 1 of 1 for report (b)(4).

• Brand Name: MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 4U I/C
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester ; 6107195000
• MDR Report Key: 9417406
• MDR Text Key: 194510869
• Report Number: 8030965-2019-70799
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07611819901643
• UDI-Public: (01)07611819901643
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.503.104.04S
• Device Lot Number: 3L80064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2019
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1