MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 13.5MM REAMER HEAD FOR RIA 2 STERILE

Model Number	03.404.023S
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device product codes: hrx.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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) 2021, the surgeon had some difficulty pushing the reamer head for ria2 shaft down the left femoral canal.The reamer tip was getting hung up on the medial cortex.To overcome this, surgeon hit the back of the drill a couple of times with a mallet; similar blows, as one would do to seat a nail a few more millimeters.The shaft was advanced using this technique and proper use of the ria2 was used.When the surgeon backed out the ria2 from the canal, there appeared to be metal shards left in the canal.The reamer head was inspected, and it was discovered that the shaft portion (opposite end of cutting flutes) had been sheared off.The surgeon reamed one more time using ria2 with a 14mm to gain more graft and hopefully push or remove those metal pieces.He was able to capture one shard and left the remaining ones in the patient¿s femur.There was a surgical delay of ten (10) minutes.Concomitant device reported: drill (part number unknown, lot unknown, quantity 1); mallet (part number unknown, lot unknown, quantity 1).This report involves one (1) 13.5mm reamer head for ria 2 sterile.This is report 1 of 1 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.Investigation flow: damage.Visual inspection: the 13.5 mm reamer head for ria 2 sterile (p/n: 03_404_024) was returned and received at us cq.Upon visual inspection, all the proximal tabs of the reamer head were observed to be broken.The embedded device was not confirmed as there were no x-rays provided.No other issues were observed with the returned device.Device failure/defect was identified.Dimensional inspection: the diameter of the tabs close to the broken part was measured to be 4.47 mm (calipers: ca215p).This is within the specification of 4.5 mm +0.00 mm/-0.05 mm per drawing 03_404_024, rev.A.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed.The complaint was confirmed.The device received was broken.Hence confirming the allegation.Investigation conclusion: the complaint condition was confirmed for the 13.5 mm reamer head for ria 2 sterile (p/n: 03_404_024, lot #: 46p3582).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.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 history lot: part number:03.404.023s.Synthes lot number: 46p3582.Supplier batch number: 6911019.Supplier lot number: n/a.Release to warehouse date: mar 26, 2020.Expiration date: feb 28, 2030.Supplier: (b)(4).No ncrs were generated during production.Device history review: 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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.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 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: 11251275
• Report Number: 2939274-2021-00550
• Device Sequence Number: 11756604
• Product Code: HTO
• UDI-Device Identifier: 10886982274045
• UDI-Public: (01)10886982274045
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/06/2021

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: 03.404.023S
• Device Catalogue Number: 03.404.023S
• Device Lot Number: 46P3582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Initial Date Received by Manufacturer: 01/06/2021
• Supplement Date Received by Manufacturer: 02/08/2021; 10/15/2021
• Initial Report FDA Received Date: 01/29/2021
• Supplement Report FDA Received Date: 02/25/2021; 10/15/2021
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0578-2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - DRILL.; UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA.; UNK - DRILL; UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Weight: 65