MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TAP FOR 4.5MM CORTEX/SHAFT SCREWS 130MM/57MM TAP DEPTH; TAP, BONE

Catalog Number	311.460
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This information is unknown.Device is an instrument and is not implanted/explanted.Reporter email address is unknown.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A device history records review has been requested.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
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that during a surgery on (b)(6) 2018, the tap for cortex screws broke and a piece of the tip remained inside the patient.The surgery was completed successfully with 15-20 minutes delay.Patient status is stable.This report is for a tap for 4.5 mm cortex/shaft screws 130 mm/57 mm tap depth.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Additional narrative: device history records review was completed for part# 311.460, lot# 311.460.Manufacturing location: (b)(4) release to warehouse date: sep 02, 2009.The device history record shows this lot of devices was processed through the normal manufacturing and inspection operations with no rework or nonconformity noted.This lot met all dimensional, visual and hardness value criteria at the time of release with no issues documented during the manufacturing process.The raw material certificate was reviewed, and the used material was according to specification for implants for surgery.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.Product development investigation was completed.Visual inspection performed at customer quality (cq) confirmed the condition of device breakage, which agrees with the reported complaint condition.A portion of the distal tip of the returned tap has broken off at an oblique angle.The broken off fragment was not returned as per the reported complaint description "small piece remained inside the patient".The material surface at the fracture site appeared homogeneous with no voids or abnormalities observed when viewed under 10x magnification at cq.Relevant drawings were reviewed during this investigation.The device was manufactured from 440a stainless steel and heat treated per es0052.No product design issues or discrepancies were observed.The major thread diameter just proximal to the break measured ø4.47mm at cq which is within specification of ø4.5mm =0.05/-0.1mm per design drawing.The shaft diameter just proximal to the threaded tip measured ø4.48mm at cq which is within specification of ø4.5mm =0/-0.04mm per design drawing.A definitive root cause for the 8+ year old tap breaking could not be determined based on the provided information.The oblique fracture angle suggests that an off axis force or contact with another metallic device may have happened.This complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation and the occurrence rate is below the expected limits.No new, unique or different patient harms were identified as a result of this evaluation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Corrected data: 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.

• Brand Name: TAP FOR 4.5MM CORTEX/SHAFT SCREWS 130MM/57MM TAP DEPTH
• Common Device Name: TAP, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7557025
• Report Number: 8030965-2018-54054
• Device Sequence Number: 13511080
• Product Code: HWX
• UDI-Device Identifier: 10886982187444
• UDI-Public: (01)10886982187444
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 311.460
• Device Lot Number: 424089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Initial Date Received by Manufacturer: 05/10/2018
• Supplement Date Received by Manufacturer: 08/02/2018
• Initial Report FDA Received Date: 05/31/2018
• Supplement Report FDA Received Date: 08/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention