MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.0MM IMF SCREW SELF-DRILLING 8MM; SCREW FIXATION INTRAOSSEOUS

Catalog Number 201.928

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 01/18/2018

Event Type  Injury  

Manufacturer Narrative

Patient¿s identifier is unknown.Device broke during insertion; device not considered implanted/explanted.An alternate device was used to complete procedural step.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(4).Without a lot number the device history records review could not be completed.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 (b)(6) as follows: it was reported that during a surgery on (b)(6) 2018, when surgeon was implanting the locking screw for the osteosynthesis of a fracture, the locking screw broke in two pieces during screwing.The screw thread fell and the rest of the screw was in the patient.They removed it by milling around the screw.This generated a delay in surgery and prolongation of the anesthesia, as the surgeon had to mill to remove the broken part of the screw.A new screw was implanted.Procedure was completed successfully.This report is for one (1) 2.0 mm imf screw self-drilling 8 mm.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

A product investigation was performed.Our investigation shows that the product in question is broken at the shaft.Furthermore we found mechanical damages at the threaded broken part.However, due to the received condition of the devices this complaint will be rates as confirmed.The review of the manufacturing documents could not be performed as no lot number is available.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 during use.Based on the investigation results we conclude that the cause of failure is not due to any manufacturing non-conformance's.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 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.

Manufacturer Narrative

The subject device has been received by the manufacturer and is undergoing investigation.The results of the investigation are pending completion and will be submitted in a supplemental report.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 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: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7263067
• MDR Text Key: 99787061
• Report Number: 8030965-2018-51024
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 07611819724358
• UDI-Public: (01)07611819724358(10)LOTNUMBERUNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 201.928
• Device Lot Number: 7740767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2018
• Initial Date FDA Received: 02/12/2018
• Supplement Dates Manufacturer Received: 02/13/2018; 04/09/2018
• Supplement Dates FDA Received: 03/13/2018; 04/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 70