MAUDE Adverse Event Report: SYNTHES BETTLACH CONICAL EXTRACTION SCREW FOR LARGE SCREWS & 4.9MM BOLTS; EXTRACTOR

Catalog Number 309.530

Device Problem Break (1069)

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

Event Date 11/12/2015

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: patient gender and weight are unknown.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.Device history record review: manufacturing site: (b)(4)- manufacturing date: august 22, 2013.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.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 a patient underwent a hardware removal revision procedure on (b)(6) 2015 due to a non-union.During the procedure, a less invasive stabilization system (liss) plate, four (4) liss screws, and three (3) locking screws were removed.The head of the last liss screw to be removed became stripped, making it difficult for the extractor to engage.The screw was drilled down further and eventually fully removed.In the process, however, the conical extraction screw broke.A fifteen (15) minute surgical delay was noted, but the patient was successfully revised to a retrograde/antegrade femoral nail.No fragments from the broken extractor were generated.The surgeon was very happy with the procedural outcome.This report will address the intra-operative events only.The non-union and revision will be captured in and reported under (b)(4).This report is 2 of 2 for (b)(4).

Manufacturer Narrative

A product investigation was completed: one (1) conical extraction screw for large screws & bolts was returned with 2.8 mm of the distal tip broken off in a spiral fashion.The distal tip was discarded during the operation so the dimension of the tip cannot be verified.It is possible that excessive force was used to remove the stripped screw which could have led to the breakage of the instrument.Based on the information provided with the complaint, a root cause could not be determined.Without the distal tip of the conical extraction screw, the dimensions of the tip could not be verified to determine its impact on the complaint condition.No design issues were noted.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CONICAL EXTRACTION SCREW FOR LARGE SCREWS & 4.9MM BOLTS
• Type of Device: EXTRACTOR
• 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5262079
• MDR Text Key: 32578355
• Report Number: 9612488-2015-10603
• Device Sequence Number: 1
• Product Code: HWB
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/12/2015

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: 309.530
• Device Lot Number: 8551706
• Other Device ID Number: (01)10886982185846(10)8551706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/12/2015
• Initial Date FDA Received: 12/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2013
• 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
• Patient Age: 71 YR