MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH IMF SCREW Ø2 L12 SST; SCREW FIXATION INTRAOSSEOUS

Catalog Number 201.932S

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 10/22/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information not available for reporting.Device malfunctioned intra-operatively and was not implanted / explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Hospital telephone not available for reporting.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 the (b)(6) as follows: it was reported that two (2) separate intermaxillary fixation (imf) screws broke during an unknown surgery on (b)(6) 2017.A drill was used to remove the broken fragments.All fragments were removed.Surgery was completed successfully with a delay of approximately 10 minutes.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Additional narrative: sterile part 201.932s, lot # l454937, manufacturing site: (b)(4), supplier: (b)(4).Release to warehouse: june 20, 2017.Expiry date: june 01, 2027.Non-sterile part 201.932, lot # l428783, manufacturing site: (b)(4).No non-conformance reports were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The manufacturing documents of the lot in question were reviewed and no complaint related issues were found.The raw-material testing certificates and the manufacturing papers regarding dimension, material analysis, strength and structural stability.The values were in compliance with the international standards for wrought stainless steel implants for surgery.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: IMF SCREW Ø2 L12 SST
• Type of Device: SCREW FIXATION INTRAOSSEOUS
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; GM 2545
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA ; 6107195000
• MDR Report Key: 7069301
• MDR Text Key: 93566853
• Report Number: 8030965-2017-50171
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 07611819747807
• UDI-Public: (01)07611819747807(17)270601(10)L454937
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K010527
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 201.932S
• Device Lot Number: L454937
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2017
• Date Device Manufactured: 06/20/2017
• 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