MAUDE Adverse Event Report: SYNTHES BETTLACH EXTRACTION BOLT FOR 2.0MM SCREWS; EXTRACTOR

Catalog Number	309.190
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.Patient id, dob, and weight not provided for reporting.Device is an instrument and is not implanted/explanted.The subject device has been received by the manufacturer and is currently undergoing investigation.The results of the investigation are pending completion and will be submitted in a supplemental report.Device history records review was requested.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that during an initial surgery for a pediatric elbow fracture of the medial epicondyle, there were multiple malfunctions.During implantation of a 3.0mm cannulated screw long thread/30mm, the cannulated cruciform screwdriver tip snapped off.The tip was retrieved.A back-up screwdriver was available for use and during implantation of the same cannulated screw, the screw broke in the middle of the shaft.The surgeon attempted to extract the screw tip, (proximal), using a extraction bolt for 2.0mm screws when the reamer snapped in half.The surgeon left the screw tip in the patient.The bottom portion (distal) of the screw remained in the patient.All fragments were retrieved as confirmed by x-ray.Multiple additional x-rays were taken due to the malfunctions.There was a one hour and 30 minute surgical delay.The surgeon successfully completed surgery and implanted a 3.0 cannulated screws in a new location around the remaining (broken) screw tip.Patient is reported as okay.This complaint involves "three (2)" devices.This report is 2 of 2 for (b)(4).
Additional Manufacturer Narrative
Corrected data: patient gender was not provided for reporting.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 or Problem Description
Concomitant devices reported: spare reamer tube for hollow reamer (part# 309.038, lot# 2670240, quantity 1).Spare reamer tube for hollow reamer (part#309.280, lot# 2028, quantity 1).Spare reamer tube for hollow reamer (part#309.280, lot# 2000015, quantity 1).Extraction bolt for 2.0mm screws (part# 309.190, lot# 2025, quantity 1).This is report 2 of 3 for (b)(4).
Additional Manufacturer Narrative
Additional narrative: device history records review was completed for part# 309.190, lot# 2802554.Manufacturing location: (b)(4), manufacturing date: dec 19, 2011.No non conformance reports were generated during production.Review of the device history records 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.
Additional Manufacturer Narrative
Product development investigation was completed.A visual inspection under 5x magnification, device history record (dhr) review and drawing review were performed at cq for the returned complaint devices, as part of this investigation.Device 2 of 3, part # 309.190, lot # 2802554, extraction bolt for 2.0mm screws.Visual inspection: this complaint is confirmed.The most distal 0.5mm (calipers ca592) is sheared off the returned bolt.No meaningful measurements could be obtained for pertinent features relevant to this complaint due to the damage.Drawing review: drawing made to revision 03 and current drawing, revision a were reviewed during this investigation.No product design issues or discrepancies were observed.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 2.0MM SCREWS
• Common Device Name: EXTRACTOR
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• MDR Report Key: 6757588
• Report Number: 9612488-2017-10377
• Device Sequence Number: 11278895
• Product Code: HWB
• UDI-Device Identifier: 10886982185662
• UDI-Public: (01)10886982185662(10)2802554
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/05/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: 309.190
• Device Lot Number: 2802554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2017
• Initial Date Received by Manufacturer: 07/05/2017
• Supplement Date Received by Manufacturer: 08/04/2017; 08/05/2017; 08/09/2017
• Initial Report FDA Received Date: 08/01/2017
• Supplement Report FDA Received Date: 08/04/2017; 08/07/2017; 08/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 14 YR