MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.0MM DRILL BIT/QC/100MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	310.19
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 during an unknown procedure of the proximal humerus on (b)(6) 2020, the 2.0mm drill bit broke.There were fragments generated which were successfully removed.It is unknown if there was a surgical delay.The procedure was successfully completed.Patient status was good.This report is for one (1) 2.0mm drill bit/qc/100mm.This is report 1 of 1 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.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device history lot part number: 310.19-us, lot number: 18p1575, part manufacturing date: 03 october 2019, manufacturing site: elmira, part expiration date: n/a, nonconformance noted: n/a.A review of the device history record revealed no complaint related anomalies.The device history record shows lot 18p1575 of 2.0 mm drill bits was processed through the normal manufacturing and inspection operations with no rework or nonconformances noted.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.A review of the component device history record(s) determined the component lot 15l4966 met all specifications with no issues documented that would contribute to this complaint condition.A review of the raw material device history record(s) determined the raw material lot h752973 met all specifications with no issues documented that would contribute to this complaint condition.A review of the device history record revealed no complaint related anomalies.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture 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.

• Brand Name: 2.0MM DRILL BIT/QC/100MM
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9740619
• Report Number: 2939274-2020-00980
• Device Sequence Number: 14072184
• Product Code: HWE
• UDI-Device Identifier: 10886982186102
• UDI-Public: (01)10886982186102
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2020

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 Model Number: 310.19
• Device Catalogue Number: 310.19
• Device Lot Number: 18P1575
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/30/2020
• Supplement Date Received by Manufacturer: 03/04/2020
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 03/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR