MAUDE Adverse Event Report: WRIGHTS LANE: SYNTHES USA PRODUCTS LLC TAP/REAMER FOR TROCHANTERIC FIXATION NAIL SCREW; TAP,BONE

Catalog Number	357.430
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient involvement.Device is an instrument and is not implanted/explanted.Complainant part has not been returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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
It was reported that the handle broke off the tap for the lag screw.There was no patient consequence.
Additional Manufacturer Narrative
Dhr review was completed.P/n 357.430, and lot number pe01312.Manufactured by supplier: (b)(4), manufacture date: 28-sept- 2011.No ncrs 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.Customer quality conducted an investigation of the returned device.The returned 6+ year old tap/reamer was returned with the handle detached from the shaft.Therefore, this complaint is confirmed.Details on whether this occurred intraoperatively or noticed preoperatively were not provided.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition.The returned instrument is used during the screw option of trochanteric fixation nail (tfn) implantations.The returned device is multi use and is used for tapping the femur prior to inserting the helical screw.No ncrs 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.The material and relevant material properties were determined to be conforming at the time of manufacture based on review of the dhr.The subject part (lot # pe01312) was manufactured using drawing.Since the time the returned part was manufactured a change has been made in order to ensure that tap/reamer handle material conforms to torque specification (10nm).The current drawing revision which added additional etch specifications and is not relevant to this complaint.Drawing was reviewed and determined to not be adequate for proper manufacturing.However, the drawing implemented a change to ensure that the tap/ reamer handle material is manufactured to withstand a torque of 10nm after being welded, and to be suitable for the intended design, application, and dimensional conformity when used and handled as recommended.A dimensional inspection was not performed at cq due to the aforementioned design change.Based on the investigation findings, it has been determined that no further corrective and/or preventative action is proposed because the design has already been updated.Corrected data: date returned to manufacturer.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
It was noted a patient was involved; it was during the case that the handle was broken.The surgeon decided that he didn¿t need to tap and continued with insertion of the lag screw.
Additional Manufacturer Narrative
Additional narrative: event, lot and udi number, device mfr date.Corrected data: device available for evaluation? 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
Patient information not available for reporting.Date returned to manufacturer.Subject device has been received and is currently in the evaluation process.Date reported in initial report was 1/12/2018.Correct date reported should have been 1/11/2018 initial reporter is synthes sales consultant.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/REAMER FOR TROCHANTERIC FIXATION NAIL SCREW
• Common Device Name: TAP,BONE
• Manufacturer (Section D): WRIGHTS LANE: SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7238626
• Report Number: 2939274-2018-50483
• Device Sequence Number: 13747484
• Product Code: HWX
• UDI-Device Identifier: 10886982196477
• UDI-Public: (01)10886982196477(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: CA
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/11/2018

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: 357.430
• Device Lot Number: PE01312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Initial Date Received by Manufacturer: 01/12/2018
• Supplement Date Received by Manufacturer: 03/01/2018; 04/06/2018; 04/13/2018
• Initial Report FDA Received Date: 02/02/2018
• Supplement Report FDA Received Date: 03/26/2018; 04/12/2018; 04/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1