MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.5 DRILL BIT WITH QUICK COUPLING/180MM; BIT MILLING STERILE AND NON

Model Number	SD310.230
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is unknown.Device is an instrument and is not implanted / explanted.(b)(6).The device was received, and the product evaluation is in progress.No conclusion can be drawn.Additionally, 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
It was reported that on an unknown date in (b)(6) 2018, patient underwent surgery for a trauma case with a broken pelvis.During the surgery, four (4) drill bits with quick coupling broke at the exact same spot.The surgeon was getting an unknown screw in the pelvis and did not have many chances.Surgeon had to risk not getting proper fixation due to the drill bit breakage.Patient had to receive a different operative plan.Reportedly, four drill bit tips remained in the patient.The procedure was completed with 30 minutes surgical delay.Patient outcome is unknown.This report is for one (1) 2.5 drill bit with quick coupling/180mm.This is report 3 of 4 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.A device history record (dhr) review was conducted.Part # sd310.230 , synthes lot # h583944 , supplier lot # na , release to warehouse date: 15may2018 , manufactured by synthes brandywine.The raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.No non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.A product investigation was conducted.The instrument was received with the reported condition of ¿broken (2+ pieces) intraoperatively: rm/si: the following investigation flow was performed: broken: it was visually observed that a portion of the distal tip has sheared off from the instrument and was not returned.The balance of the device is in fair condition.The complaint condition is confirmed and the received condition agrees with the complaint description.The cause of the issue could not be definitively traced to use error, misuse/abuse, non-compliance, postoperative trauma.Dimensional inspection was performed per relevant drawing.Diameter of distal tip proximal to tip breakage: ø 2.5 +/- 0.2 mm; measured dimensions: shaft ø: 2.49 mm; conforming, a review of the current design drawing was performed: no issues were identified.While no definitive root cause could be determined it is possible that any unintended forces encountered by the device during usage or handling could have contributed to complaint condition.The raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.During the investigation, no product design or manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: 2.5 DRILL BIT WITH QUICK COUPLING/180MM
• Common Device Name: BIT MILLING STERILE AND NON
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7865151
• Report Number: 2939274-2018-53723
• Device Sequence Number: 16635180
• Product Code: GFG
• UDI-Device Identifier: 10886982003973
• UDI-Public: (01)10886982003973
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2018

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 Model Number: SD310.230
• Device Catalogue Number: SD310.230
• Device Lot Number: H583944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Initial Date Received by Manufacturer: 08/23/2018
• Supplement Date Received by Manufacturer: 10/12/2018
• Initial Report FDA Received Date: 09/11/2018
• Supplement Report FDA Received Date: 10/15/2018
• 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