MAUDE Adverse Event Report: SYNTHES BETTLACH EXTRACTION BOLT FOR 3.5MM & 4.0MM SCREWS; EXTRACTOR

Catalog Number 309.039

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/05/2017

Event Type  Injury  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.A device history record (dhr) review was performed for part # 309.039, lot # 2535491: manufacturing location: (b)(4).Manufacturing date: 02 november 2009: no non-conformance reports (ncrs) were generated during production that would contribute to the complaint condition.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.The device has been received and the product evaluation is in progress.No conclusion can be drawn.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 initially a patient underwent a placement of a medial malleolar screw for an ankle valgus on an unknown date to correct a deformity.A hardware removal was scheduled on (b)(6) 2017 due to the deformity healing.During the removal, a 4.0mm cannulated screw stripped.As the surgeon was removing the screw from the medial malleous, the screw head stripped.The surgeon used pliers to back the screw out.The head then broke off, so the surgeon used a trephine to open around the shaft of the screw.The trephine then broke off inside the patient.The surgical team then used a conical extractor to remove the screw shaft.The screw then broke off inside the patient.Using the hardware removal tools to extract the screw, the surgery was able to be completed with the removal of the entire screw.There was about a ten (10) minute surgical delay.The patient status is good.Concomitant devices reported: pliers (part # unknown, lot # unknown, qty 1), conical extractor (part # unknown, lot # unknown, qty 1); hardware removal tools (part # and lot # unknown, quantity unknown) this report is for one (1) extraction bolt for 3.5mm & 4.0mm screws this is report 4 of 4 for complaint (b)(4).

Manufacturer Narrative

Product development investigation was completed on p/n 309.039 extractor.The investigation summary indicates that: this complaint involves 4 parts.Customer quality (cq) engineering investigation: complaint condition of ¿broken ¿ intraoperatively¿ was confirmed for the two out of four devices which are unknown cannulated screw and the reamer tube p/n 309.480.Conical screw extractor p/n 309.039 and the hollow reamer (p/n 309.450) were found to be intact with no broken or missing fragments during cq investigation.The replication of the complaint condition at customer quality (cq) is not applicable for the broken devices as the devices were visibly confirmed to be broken.The fragment of the screw was received stuck inside the conical extractor (p/n 309.039) and the hollow reamer (p/n 309.450) was found stuck with the reamer tube p/n 309.480 on the coupling end.The two devices could not be separated using pliers at the cq location.The overall complaint is confirmed.Visual inspection, device history record (dhr) review, dcrm review and drawing review were performed as part of this investigation.P/n 309.039 extractor: screw removal technique guide was referred during this investigation.It was verified that the recommended extraction bolt and hollow reamer (p/n 309.450) combination (per the technique guide) was used for the 4.0 mm screws.As per complaint description, the bone was healed (deformity healing) prior to the extraction of the broken screw.This condition would tend to introduce additional resistance during screw stem extraction due to bony growth around the stem.Technique guide also recommends to hold the extraction bolt as vertical as possible during the entire extraction process.Failure to do so, may end up in the observed complaint condition.The exact root cause could not be determined.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Review of the device history record showed that there were no issues with the material, hardness and during the manufacturing of this product that would contribute to this complaint condition.Additionally, the calculated occurrence rate is acceptable with the applicable design and clinical risk management occurrence rate.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.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.

• Brand Name: EXTRACTION BOLT FOR 3.5MM & 4.0MM SCREWS
• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6991485
• MDR Text Key: 90715302
• Report Number: 9612488-2017-10549
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10886982185563
• UDI-Public: (01)10886982185563(10)2535491
• 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: 10/09/2017

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: 309.039
• Device Lot Number: 2535491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/09/2017
• Initial Date FDA Received: 10/31/2017
• Supplement Dates Manufacturer Received: 12/05/2017
• Supplement Dates FDA Received: 12/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2009
• 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: CONICAL EXTRACTOR (PART & LOT # UNKNOWN, QTY 1); HARDWARE REMOVAL TOOLS (PART & LOT UNK, QTY UNK); PLIERS (PART # UNKNOWN, LOT # UNKNOWN, QTY 1)
• Patient Outcome(s): Required Intervention
• Patient Age: 15 YR
• Patient Weight: 54