MAUDE Adverse Event Report: SYNTHES OBERDORF INSERTN HANDLE F/3.5MM LOW BNDMEDIAL DISTAL TIBIA PLATE/LEFT; GAUGE, DEPTH

Catalog Number 03.113.026

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: it is unknown when the screws came to be missing.Device is an instrument and is not implanted or explanted.Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.Service history review: no service history review can be performed as this is a lot controlled item.The manufacture date of this item is december 30, 2010.The source of the manufacture date is the release to warehouse date.The service history evaluation is unconfirmed.Device 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

It was reported that two (2) insertion handles for low bend, medial distal tibia plates (one right, one left) are missing a set screw.Both devices are missing the small screws that go into the guide in order to attach to the plate, thus rendering the instruments unusable.The issue was discovered during set check of the devices upon receipt of the shipment.No patient or procedural involvement.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

A service and repair evaluation was completed: the customer reported the set screw was missing.The repair technician reported the threads on the handle were damaged.Threads stripped is the reason for repair.The item is not repairable.The cause of the issue is unknown.The item will be forwarded to the complaint handling unit.The evaluation was confirmed.A product investigation was completed: the complaint condition is confirmed as the screw was missing upon receipt and the threads were noted to be stripped.A definitive root cause was unable to be determined; however, the failure mode is consistent with rough handling/misuse.It is most probable that the missing component portion of the complaint condition is a result of disassembly for cleaning, and subsequent loss of the component and/or improper reassembly of the device and that the stripped threads portion of the complaint condition is a result of excessive tightening.The returned part was determined to be suitable for the intended use when employed and maintained as recommended and the risk assessment was found to adequately address the complaint condition.Per the technique guide, the insertion handle is intended for use in percutaneous insertion and alignment of locking compression plates (lcp) low bend medial distal tibia plates.It connects directly to the plate on the distal end and to the aiming arm on the proximal end.Information is provided per the 3.5mm lcp low bend medial distal tibia plate aiming instruments technique guide.The insertion handle was received with the m3.5 screw missing.The threads intended to mate with the set screw show wear and appear slightly stripped.The balance of the device is in working condition.Thus, the complaint condition is confirmed and consistent with the reported condition.Replication of the complaint condition is not applicable as the set screw is already missing.A review of the current design drawing / manufactured revision for the top level assembly, the m3.5 screw and the insertion handle component was performed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.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: INSERTN HANDLE F/3.5MM LOW BNDMEDIAL DISTAL TIBIA PLATE/LEFT
• Type of Device: GAUGE, DEPTH
• Manufacturer (Section D): SYNTHES OBERDORF; eimattstrasse 3; oberdorf CH443 6; SZ CH4436
• Manufacturer (Section G): SYNTHES OBERDORF; eimattstrasse 3; oberdorf CH443 6; SZ CH4436
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5292850
• MDR Text Key: 33400237
• Report Number: 8030965-2015-12292
• Device Sequence Number: 1
• Product Code: HTJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Equipment Company Technician/Representative
• Device Catalogue Number: 03.113.026
• Device Lot Number: 3621415
• Other Device ID Number: (01)10886982072924(10)3621415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/30/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1