MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 15 REAM GUIDE 2.4 VAL INTERCARP FUSN PL; SCREW,FIXATION,BONE

Model Number	03.111.036
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).Reporter is a j&j sales representative.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 an unknown date, during routine inspection of instruments, it was noticed that the reamer guide was broken, and k-wire was jammed.There was no procedure or patient involvement.This complaint involves two (2) devices.This report is for (1) 15 ream guide 2.4 val intercarp fusn pl.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: d7a.H3, h6: a product investigation was conducted.Visual inspection: the 15 ream guide 2.4 val intercarp fusn pl (part #: 03.111.036, lot #: 2706933) was returned and received at us cq.Upon visual inspection, no issues were observed with the returned device.Investigation conclusion: the complaint condition was confirmed for the 15 ream guide 2.4 val intercarp fusn pl (part #: 03.111.036, lot #: 2706933) as no broken features were observed.No definitive root-cause can be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that 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.H3, h4, h6: a device history record (dhr) review was conducted: part #: 03.111.036.Lot #: 2706933.Manufacturing site: bettlach.Release to warehouse date: 28 march 2011.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.G1; g2.

• Brand Name: 15 REAM GUIDE 2.4 VAL INTERCARP FUSN PL
• Common Device Name: SCREW,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11915930
• Report Number: 2939274-2021-02704
• Device Sequence Number: 19754242
• Product Code: HWC
• UDI-Device Identifier: 10886982072344
• UDI-Public: 10886982072344
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103243
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2021

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: 03.111.036
• Device Catalogue Number: 03.111.036
• Device Lot Number: 2706933
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2021
• Initial Date Received by Manufacturer: 05/05/2021
• Supplement Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 06/01/2021
• Supplement Report FDA Received Date: 06/24/2021
• 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 - GUIDE/COMPRESSION/K-WIRES