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 11/16/2016

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: patient id/initials, age/date of birth, and weight are unknown.Device is an instrument and is not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 the patient underwent a tibia osteotomy on (b)(6) 2016 for removal of existing synthes hardware for an adjustment and re-cut of osteotomy that was requested by the patient.Reportedly, the patient did not have any complaints of pain/discomfort prior to the hardware removal.The patient was originally implanted on an unknown date with one (1) tomofix plate, six (6) 5.0mm locking screws and two (2) 4.5 cortical screws.During the revision all synthes hardware was removed and the new synthes hardware implanted included: one (1) 4.5 locking compression plate proximal tibia - left 10 hole plate, five (5) locking screws, two (2) 6.5mm cancellous screws, and three (3) 4.5 cortical screws.During the hardware removal one locking screw was cold welded to the tomofix plate and the surgeon tried using a 5.0 conical extraction screw to remove the screw, but it broke mid shaft.The surgeon tried using a quick coupling t-chuck but the metal shaft broke at the intersection of the t.Fragments were easily retrieved after each instrument broke.A routine x-ray was taken during the surgery.No additional intervention was necessary.The surgeon then used a universal chuck with t-handle and it subsequently bent while removing the screw.There was a five (5) minute delay.No harm was reported to the patient.The procedure was successfully completed.Concomitant device reported: tomofix plate (part/lot unknown, quantity 1).This is report 2 of 3 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Part number: 309.530, synthes lot number: 8129637: release to warehouse date: nov 29, 2012.Mfg.Site: (b)(4).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 this product that would contribute to this complaint condition.A product investigation was performed.The following complained device was received by customer quality (cq): one conical extraction screw for large screws and 4.9mm bolts (part number: 309.530, lot number: 8129637, mfg.Date: 29nov2012).The part was received with the following complaint description: ¿during the hardware removal one locking screw was cold welded to the tomofix plate and the surgeon tried using a 5.0 conical extraction screw to remove the screw but, it broke mid shaft.The surgeon tried using a quick coupling t-chuck but the metal shaft broke at the intersection of the t.Fragments were easily retrieved after each instrument broke.A routine x-ray was taken during the surgery.No additional intervention was necessary.The surgeon then used a universal chuck with t-handle and it subsequently bent while removing the screw.There was a 5 minute delay.No harm was reported to the patient.The procedure was successfully completed.¿ the complaint condition is confirmed.A visual inspection, complaint history review, and drawing review were performed as part of this investigation.The conical extraction screw is part of the synthes screw removal set.The instruments are used to remove intact screws or damaged screws that are difficult to remove.The returned instrument was examined and it can be seen that the threaded distal tip of the instrument has broken off from the instrument and was not returned.Approximately 4.42mm of the device had sheared off.Replication of the complaint condition is not applicable as the instrument as it¿s already broken.The returned part was determined to be suitable for its intended use when employed and maintained as recommended.It is likely caused during a procedure where a surgeon was trying to remove an implanted screw and it had become hardened making it difficult to remove without some sort of force which lead to the bending of the universal chuck and the breaking of both the t-handle and conical extraction screw in attempt to remove it.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 PA 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: 6157800
• MDR Text Key: 62326690
• Report Number: 2520274-2016-15639
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 11/16/2016

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: 8129637
• Other Device ID Number: (01)10886982185846(10)8129637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/16/2016
• Initial Date FDA Received: 12/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2012
• 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
• Treatment: 1 UNKNOWN TOMOFIX PLATE