MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 13.0MM REAMER HEAD FOR RIA 2 STERILE

Model Number	03.404.022S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Investigation summary: the instrument(s) was not returned and instead the investigation will be done based on the supplied image(s) located in notes & attachments section of the product complaint.The image(s) was reviewed and the complaint condition for broken could be confirmed as the images provided shows the separated sub-components.As the instrument(s) was not returned an as received condition, dimensional inspection, material or drawing reviews are not applicable.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history: part number: 03.404.022s, synthes lot number: 33p1495, supplier lot number: n/a, release to warehouse date: 10dec2019, expiration date: 30oct2039, supplier: jabil monument.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Device was used for treatment, not diagnosis.
Event or Problem Description
It was reported that on august 18, 2020, while harvesting bone graft right femur, the reamer irrigator aspirator (ria) had trouble making the turn around the medial cortex, and the head tines sheared off.The surgeon retrieved the broken pieces and continued with a new kit.Fragments were removed easily without additional intervention.There was a surgical delay of thirty (30) minutes.The procedure was successfully completed.There was no patient consequences.This is report 1 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: visual inspection: the 13.0mm reamer head for ria 2 sterile was received at us customer quality (cq).Upon visual inspection, it was noticed that the proximal end of the reamer where it is inserted into the drive shaft has completely broken off and one of the broken pieces was not returned.No other issues were identified with the device.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Document/specification review: 13.0mm reamer head ria2.Conclusion: the complaint condition is confirmed for the 13.0mm reamer head for ria 2 sterile.There was no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.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.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: 13.0MM REAMER HEAD FOR RIA 2 STERILE
• Common Device Name: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10534772
• Report Number: 2939274-2020-04120
• Device Sequence Number: 19801561
• Product Code: HTO
• UDI-Device Identifier: 10886982274021
• UDI-Public: (01)10886982274021
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2020

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: 03.404.022S
• Device Catalogue Number: 03.404.022S
• Device Lot Number: 6778007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Initial Date Received by Manufacturer: 08/18/2020
• Supplement Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 09/15/2020
• Supplement Report FDA Received Date: 10/02/2020
• 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: 13.0MM REAMER HEAD FOR RIA 2 STERILE; RIA 2 BONE HARVESTING KIT 520MM STERILE
• Patient Age: 6 DA
• Patient Weight: 77