MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM; SCREW, FIXATION, INTRAOSSEOUS

Catalog Number 04.503.206.04S

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 07/31/2020

Event Type  malfunction  

Manufacturer Narrative

The returned matrixmidface screw is broken just below the screw head.The broken off screw shaft was not returned as it remained in patients¿s bone.The cruciform screw recess shows normal signs of use.The complaint condition is confirmed as the screw head is broken off.This production lot was manufactured in october 2019 according to the specifications.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements.The correct material was used.A manufacturing related issue can be excluded.A definitive root cause for the screw breakage could not be determined based on the provided information.We can only assume that too much force was applied during screw insertion.These devices can break during use (when subjected to excessive forces or outside the recommended surgical technique).Be aware that implants are not as strong as native bone.Implants subjected to substantial loads may fail.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot part: 04.503.206.04s, lot: 22p2565, manufacturing site: (b)(4), release to warehouse date: (b)(4) 2019, expiry date: 01.Oct.2029.A manufacturing record evaluation was performed for the finished device part: 04.503.206.04s, lot: 22p2565, and no non-conformance's were identified.Since there is no allegation against packing or sterility dhr review is done for non-sterile part: part number: 04.503.206.20, lot number: 3l39469, manufacturing site: (b)(4), manufacturing location: (b)(4), manufacturing date: 04-jun-2019, part number: 04.503.206.20, ti matrixmidface screw self- tapping 6mm, lot number: 3l39469 (non-sterile), component part(s) reviewed: part number: 21015, tialnbri4.00, lot number: h851352, this lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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 (b)(6) 2020, the patient underwent open reduction internal fixation surgery.During the procedure, the surgeon opened the package of the screws and one of the screws only contained the screw head.The surgeon used another screw to successfully complete the procedure without surgical delay.No further information is available.Concomitant device reported: unk - screwdriver: (part#: unknown; lot#: unknown; quantity: 1).This report is for one (1) ti matrixmidface screw self-tapping 6mm.This is report 1 of 1 for (b)(4).

• Brand Name: TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM
• Type of Device: SCREW, FIXATION, INTRAOSSEOUS
• 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, PA 19380 ; 6103142063
• MDR Report Key: 10546586
• MDR Text Key: 207341991
• Report Number: 8030965-2020-07137
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 07611819908833
• UDI-Public: (01)07611819908833
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K083388
• 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: 08/03/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 04.503.206.04S
• Device Lot Number: 22P2565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/17/2020
• Initial Date FDA Received: 09/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - SCREWDRIVERS