MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM FLEXIBLE SHAFT; REAMER

Model Number 352.040

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Patient Involvement (2645)

Event Date 05/22/2019

Event Type  malfunction  

Manufacturer Narrative

Reporter is a synthes employee.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 Description

It was reported that upon routine inspection of the flexible reamer set on (b)(6) 2019, it was noticed that two (2) flexible reamer shafts did not properly secure the reamer head attachments.There was no patient involvement.Concomitant devices: reamer head (part: unknown, lot: unknown, quantity: unknown).This report is for a 5.0mm flexible shaft.This is report 2 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: the 5.0mm flexible shaft (p/n 352.040 lot 2097791) was received with slightly deformed distal coupling prongs.All four (4) prongs were slightly bent inwards, towards the center of axis, narrowing the coupling tip cannulation.No other issues were identified with the returned components of the device.Functional testing of device interaction could not be completed as the mating reamer head(s) was not returned.The reported complaint condition could not be replicated as the mating reamer head(s) was not returned.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The complaint condition is confirmed for the 5.0mm flexible shaft (p/n 352.040 lot 2097791) as the distal coupling prongs were slightly deformed.All four (4) prongs were slightly bent inwards, towards the center of axis, narrowing the coupling tip cannulation.The deformed coupling tip can cause the reamer shaft to not properly secure the reamer heads.While no definitive root cause could be determined, it is possible that the instrument condition is due to excessive forces or repeated use/reprocessing over the part¿s lifetime (14+ years).During this investigation no product design or manufacturing issues were observed 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 lot : part: 352.040, lot: 2097791, manufacturing site: (b)(4), release to warehouse date: 11.August 2004.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: 5.0MM FLEXIBLE SHAFT
• Type of Device: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8716790
• MDR Text Key: 148624666
• Report Number: 2939274-2019-58780
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10886982194114
• UDI-Public: (01)10886982194114
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/22/2019

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
• Device Operator: Health Professional
• Device Model Number: 352.040
• Device Catalogue Number: 352.040
• Device Lot Number: 2097791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2019
• Initial Date Manufacturer Received: 05/22/2019
• Initial Date FDA Received: 06/20/2019
• Supplement Dates Manufacturer Received: 06/27/2019
• Supplement Dates FDA Received: 07/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - REAMERS: REAMER HEAD; UNK - REAMERS: REAMER HEAD