MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.0MM THREADED DRILL GUIDE FOR 1.3MM LOCKING PLATES

Model Number	03.130.120
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product code hxx.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 (b)(6) 2020, during an unknown procedure, the unknown 1.5mm drill bit was mistakenly run to the threaded drill guide instead of a 1.1mm unknown drill bit.So, the unknown 1.5mm drill bit broke and lodge into the power.The procedure was completed successfully with no surgical delay.The patient outcome was unknown.This complaint involves 2 devices.This report is for (1) 1.0mm threaded drill guide for 1.3mm locking plates.This report is 1 of 2 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d7.H3, h4, h6: part: 03.130.120.Lot: 9820850 manufacturing site: bettlach.Release to warehouse date: april 05, 2016.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: 1.0mm threaded drill guide for 1.3mm locking plates was returned and received at us customer quality (cq).Upon visual inspection at cq, it is observed that the most distal tip of the device got broken.Rest of the device shows normal wear consistent with the device which would not contribute to the complaint condition.Thus, the complaint is being confirmed.Dimensional inspection: dimensional inspection of the received device was not performed at cq due to post manufacturing damage.Document/specification review: the following drawings were reviewed during the investigation: -1.3 locking drill guide no design issues or discrepancies were noticed.Investigation conclusion.The complaint condition was confirmed for the 1.0mm threaded drill guide for 1.3mm locking plates.While a definitive root cause for the reported problem cannot be determined, it is possible that the device might have encountered unintended forces.There were no issues during the manufacture of this product that would contribute to this complaint condition.During the investigation, no product design issues, or discrepancies were observed that may have contributed to the complaint condition.Based upon these results, no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive 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.D4.E1.

• Brand Name: 1.0MM THREADED DRILL GUIDE FOR 1.3MM LOCKING PLATES
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11147288
• Report Number: 2939274-2021-00146
• Device Sequence Number: 3607719
• Product Code: FZX
• UDI-Device Identifier: 10886982075277
• UDI-Public: (01)10886982075277
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2020

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: 03.130.120
• Device Catalogue Number: 03.130.120
• Device Lot Number: 9820850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2020
• Initial Date Received by Manufacturer: 12/14/2020
• Supplement Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 02/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - DRILL BITS: TRAUMA.; UNK - DRILL BITS: TRAUMA
• Patient Age: 27 YR