MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SILICONE HANDLE QUICK COUPLING/LONG; MISC ORTHO SURGICAL INSTR

Model Number	03.111.012
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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 unknown date, the patient underwent for a procedure.During the procedure, the surgeon was using the bone harvesting instrument set to collect iliac bone graft.He used a mallet to hit the end of the handle in order to get the trephine to sink into the bone.When surgeon tried to pull the handle, the trephine stayed in the bone and the distal end of the shaft for the trephines broke off.The pin on the quick connect release portion of the handle broke off as well.The distal end of the shaft for the trephines broke off.There was no surgical delay noted.Fragments generated was removed successfully.The procedure was successfully completed.Patient status is unknown.Concomitant device reported: unk - mallet (part#: unknown, lot#: unknown, quantity: 1).This complaint involves two (2) devices.This report is for (1) silicone handle quick coupling/long.This report is 2 of 3 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.H3, h6: part: 03.111.012, lot: 2550624, manufacturing site: bettlach, release to warehouse date: 22.Jan.2010.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the silicone handle quick coupling/long (part #: 03.111.012, lot #: 2550624) was received at us customer quality (cq).Upon the visual inspection, the slid-sleeve f/handle w/quick-couple, the spring were unattached to the device and the dowel pin was observed to be missing.Nicks were also observed on the device.Device failure/defect identified? yes.Dimensional inspection: measured dimensions: medium shaft od = conform big od = conform.Document/specification review: the device was manufactured to previous design before implementing the design changes per the following capas.Design change of chisel handles 03.111.012 / 013.Complete redesign of the coupling mechanism and design of the handle.The design change was implemented related to breakage of the holding pin as well as jamming of the mating devices.Complaint confirmed? yes.Investigation conclusion: the complaint condition is confirmed for the silicone handle quick coupling/long (p/n: 03.111.012, lot #: 9763175).Capa and design change were completed in 25-mar-2010 and the em failed due to sustained complaint volume.Thus, the capa addressed the pin breakage.It was completed in 04-oct-2013.This capa was later extended where plans were evaluated for a complete design over haul, design change was completed in august of 2017.No manufacturing issues were identified through the investigation.A corrective and/or preventive action has already been launched and completed to address the design deficiency.See related actions.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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: SILICONE HANDLE QUICK COUPLING/LONG
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12422660
• Report Number: 2939274-2021-05180
• Device Sequence Number: 3609649
• Product Code: LXH
• UDI-Device Identifier: 10886982072115
• UDI-Public: (01)10886982072115
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 08/05/2021

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: 03.111.012
• Device Catalogue Number: 03.111.012
• Device Lot Number: 2550624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Initial Date Received by Manufacturer: 08/05/2021
• Supplement Date Received by Manufacturer: 09/10/2021
• Initial Report FDA Received Date: 09/03/2021
• Supplement Report FDA Received Date: 09/28/2021
• 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: SHAFT FOR TREPHINE ATTACHMENTS; UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA; SHAFT FOR TREPHINE ATTACHMENTS; UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA