MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 13.5MM REAMER HEAD-STERILE FOR REAMER/IRRIGATOR/ASPIRATOR

Model Number	352.253S
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 during an open reduction internal fixation (orif) of the ankle on (b)(6) 2020, during insertion of the initial reamer/irrigator/aspirator (ria) shaft, it would not advance like usual.The surgeon kept pushing and spinning and after about 1m the ria head broke at the legs along with the ria shaft tip inside the canal.The fragments were completely removed from the canal.It was not realized that the tip of the shaft was broken until after a second try with a another ria head.Eventually the surgeon went down to a smaller ria head and new ria shaft and achieved bone graft into the filter.The procedure was successfully completed with other medical intervention and 30 minutes surgical delay.There was a patient consequence reported.This complaint involves three (3) devices.This is report 2 of 3 for (b)(4).
Event or Problem Description
There were some very small metal fragments in the ria bone graft that were re-inserted back into the defect in order to stimulate healing.
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 # 352.253s, synthes lot # 14l1969, supplier lot # 14l1969, release to warehouse date: 17 feb 2020, expiration date: 31 dec 2028, supplier: (b)(4).No ncr's were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Visual inspection: the 13.5mm reamer head-sterile for reamer/irrigator/aspirator( p/n: 352.253s; lot # 14l1969) 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 broken off and the broken pieces were not returned.The reported condition of embedded device was not confirmed as there is no evidence found in the images/x-rays provided.No other issues were identified with the device.Device failure/ defect identified? yes.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Document/specification review: - 13.5mm reamer head ria.Complaint confirmed? yes; received device was broken.Conclusion: the complaint condition is confirmed for the 13.5mm reamer head-sterile for reamer/irrigator/aspirator( p/n: 352.253s; lot # 14l1969).The reported condition of embedded device was not confirmed as there is no evidence found in the images/x-rays provided.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: 13.5MM REAMER HEAD-STERILE FOR REAMER/IRRIGATOR/ASPIRATOR
• Common Device Name: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10928088
• Report Number: 2939274-2020-05375
• Device Sequence Number: 13985108
• Product Code: HTO
• UDI-Device Identifier: 10886982194480
• UDI-Public: (01)10886982194480
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K111437
• 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): 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 352.253S
• Device Catalogue Number: 352.253S
• Device Lot Number: 14L1969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Initial Date Received by Manufacturer: 11/04/2020
• Supplement Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 12/17/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA; DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 27 YR