MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 14.0MM REAMER HEAD-STERILE FOR REAMER/IRRIGATOR/ASPIRATOR

Model Number 352.254S

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2020

Event Type  malfunction  

Manufacturer Narrative

Additional product code: hrx.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed, no product was received; 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 Description

It was reported that on (b)(6) 2020, during an unknown procedure there are two products that involved these are the reamer head-sterile for reamer/irrigator/aspirator and drive shaft-minimum 520mm length for use with ria.Both the ria drive shaft and ria head broke where they attach to each other.There was a surgical delay only a couple of minutes.Procedure was successfully complete the other ria drive shaft and new head was used successfully.Patient was involved but there is no adverse events.Patient status was good after surgery.This complaint involves two (2) devices.This report is for (1) 14.0mm reamer head-sterile for reamer/irrigator/aspirator.This report is 1 of 2 for (b)(4).

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.Visual inspection: the 14.0mm reamer head-sterile for reamer/irrigator/aspirator (part #: 352.254 and lot #: h442070) was returned and received at us cq.Upon visual inspection, the reamer head was cracked and broken.No other issues were identified with the returned device.Device failure/defect was identified.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.Document/specification review based on the date of manufacture, the current and manufactured revision of drawings were reviewed.Complaint was confirmed.Investigation conclusion the complaint condition is confirmed as the device received was broken.There is no indication that a design or manufacturing issue has caused the issue 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:352.254s, synthes lot number: h442070, supplier lot number: n/a, release to warehouse date: jan 15, 2018, expiration date: dec 31, 2026, manufactured by synthes monument.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.

• Brand Name: 14.0MM REAMER HEAD-STERILE FOR REAMER/IRRIGATOR/ASPIRATOR
• Type of Device: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11013133
• MDR Text Key: 222394271
• Report Number: 2939274-2020-05595
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10886982194503
• UDI-Public: (01)10886982194503
• Combination Product (y/n): N
• PMA/PMN Number: K111437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 352.254S
• Device Catalogue Number: 352.254S
• Device Lot Number: H442070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Date Manufacturer Received: 12/30/2020
• Patient Sequence Number: 1
• Treatment: DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA
• Patient Age: 67 YR