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 Sedation (2368)

Event Date 10/26/2015

Event Type  Injury  

Manufacturer Narrative

(b)(6).Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Manufacturing location: (b)(4).Manufacturing date: 21november2013.No non-conformance reports 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.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

It was reported that a 4.9 mm titanium locking screw stripped and two conical extraction screws broke during a hardware removal due to avascular necrosis of the femoral head performed on (b)(6) 2015.The date of the original procedure was approximately eleven (11) years ago.Removed hardware included four (4) intact 4.9 mm titanium locking screws.The original intention was to remove all hardware (titanium femoral nail with four (4) 4.9mm locking bolts of the 459.Xx family) on (b)(6) 2015 in preparation for a conversion to a total hip arthroplasty.The ¿male¿ conical extraction screw was screwed into the recess of the forth screw and it broke off into the recess (completely frozen in there).The ¿female¿ conical extraction screw was then tried, and that broke also.A hollow reamer was then used to ream over the screw head, on both medial and lateral sides of the nail.The screw was then removed successfully.There was a reported sixty (60) minute surgical delay.No fragments left behind.The procedure was completed without further incident.The nail is planned to be removed at a later, unknown date.This is report 1 of 3 for (b)(4).

Manufacturer Narrative

Conical extraction screw for large screws & 4.9mm bolts (part number: 309.530, lot number: 8662258.Upon visual inspection of the complaint device it can be seen that the threaded distal tip of the instrument has broken off from the instrument and was not returned.Approximately 2.25 mm of the device had sheared off.A root cause could not be determined; a possible cause could be the screw that was trying to being removed had become hardened after being in the patient¿s anatomy for approximately 11 years and made it difficult to remove without some force which lead to breaking of the tip on the instrument in attempt to remove it.This complaint is confirmed.The design history was found to not impact the complaint condition.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.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: 5225757
• MDR Text Key: 31261485
• Report Number: 9612488-2015-10566
• 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: 10/26/2015

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: 309.530
• Device Lot Number: 8662258
• Other Device ID Number: (01)10886982185846(10)8662258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/26/2015
• Initial Date FDA Received: 11/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2013
• 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 Outcome(s): Required Intervention
• Patient Age: 27 YR
• Patient Weight: 61