MAUDE Adverse Event Report: SYNTHES BETTLACH 2.0MM IMF SCREW SELF-DRILLING 8MM; SCREW FIXATION INTEROSSEOUS

Catalog Number 201.928

Device Problems Break (1069); Material Fragmentation (1261)

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

Event Date 03/16/2017

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: patient information is not available for reporting.An event date of (b)(6) 2017 was reported; however, it is unknown if this is the date the screw broke or if this is the date the broken screw was discovered.(b)(4).An implant date of (b)(6) 2017 was reported; however, it is unknown if this was the date the screw was implanted and the screw broke postoperatively on an unknown date or if this was the date of the implantation surgery in which case, an implant date would not be applicable.Explant date: unknown.The subject device is expected to be returned to the synthes manufacturer for evaluation but has not yet been received.(b)(6).The 510(k): device is not distributed in the united states, but is similar to device marketed in the usa.The investigation could not be completed; no conclusion could be drawn, as no product was received.Without a lot number the device history records review could not be completed.The date of manufacture is unknown.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Synthes europe reported an event in (b)(6) as follows: it was reported that the intermaxillary fixation screw (imf) broke in the patient's upper jaw.The half of the screw was retained in the bone.There was no information about patient condition and surgical outcome available for reporting.It is unknown if the screw broke intra-operatively or post-operatively.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device is not expected to be returned for manufacturer review/investigation.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

The primary surgery was performed because the patient dropped from his height on the chin.The duration of the intervention does not seem to have been significantly increased following this incident.Patient impact is that half of the screw is still inside the patient.No other procedure is planned to remove the screw.The overhanging part was milled by the surgeon.The rest of the screw remained n place.The delay was a few minutes.The patient is fine and beside the breakage of the screw, the procedure successfully completed.

Manufacturer Narrative

Device returned to manufacturer.A product investigation was performed.The screw was found broken at threaded shaft.The broken part, approx.6 mm, is missing.It was not possible to perform dhr review as no lot number was provided and no laser etching is visible on part.Actual drawing does not request any laser etching on part, therefore no marking issue could be found.Unfortunately we are not able to determine the exact cause which has led to this occurrence.The view of the broken surfaces does not show any anomalies of materials structure, what indicates material conformity as well.Because of the damage, the complaint relevant dimensions cannot be checked for dimensional accuracy of the valid manufacturing specifications.Unfortunately we only have limited information in the complaint description and cannot confirm how this happened.We do suppose that the cause of the breakage is the result of a mechanical overload situation.Finally we conclude that the cause of failure is not due to any manufacturing non-conformances.No product fault could be detected 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: 2.0MM IMF SCREW SELF-DRILLING 8MM
• Type of Device: SCREW FIXATION INTEROSSEOUS
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6470861
• MDR Text Key: 72344548
• Report Number: 9612488-2017-10162
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010527
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 03/21/2017

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: 201.928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2017
• Initial Date FDA Received: 04/07/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/01/2017; 06/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 19 YR