MAUDE Adverse Event Report: SYNTHES SELZACH IMF SCREW Ø2 L12 SST; SCREW FIXATION INTRAOSSEOUS

Catalog Number 201.932S

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/29/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device malfunctioned intra-operatively and was not implanted / explanted.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.Concomitant reported parts: 1x unknown instrument to retrieve broken portion of screw device history records review was conducted.The report indicates that the: part #201.932s / lot #l454937 please note, this dhr review is for sterilization procedure only: manufacturing location: (b)(4) supplier: (b)(4).Manufacturing date: 20.Jun.2017 expiry date: 01.Jun.2027 no 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.Non-sterile 201.932 / l428783 was manufactured in mezzovico manufacturing location: (b)(4) manufacturing date: 29.May.2017 no 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.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 on an event in (b)(6) as follows: it was reported that during surgery on (b)(6) 2017 the intermaxillary fixation screw (imf) broke while engaging into the mandible.Despite many efforts trying to retrieve the broken section of the screw from the jaw it was decided to leave the fragment in the patient.This complaint involves 1 parts.Concomitant reported parts: 1x unknown insertion instrument, 1x unknown instrument to retrieve broken portion of screw.This report is 1 of 1 for (b)(4).

• Brand Name: IMF SCREW Ø2 L12 SST
• Type of Device: SCREW FIXATION INTRAOSSEOUS
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6956861
• MDR Text Key: 90415630
• Report Number: 3000270450-2017-10365
• Device Sequence Number: 1
• Product Code: DZL
• 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: Other
• Type of Report: Initial
• Report Date: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• 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?: No
• Date Manufacturer Received: 09/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1