MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12.0MM/8.0MM PROTECTION SLEEVE 188MM; MISC ORTHO SURGICAL INSTR

Catalog Number 03.010.063

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device history lot part number: 03.010.063, synthes lot number: 4818407, supplier lot number: n/a, release to warehouse date: 04-feb-2005, expiration date: n/a, manufactured by synthes brandywine.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.Investigation summary: customer quality investigation: device condition: visual inspection performed at customer quality identified scratches, nicks and a dented/ interiorly flared edge on inner cannulation surface at the distal sleeve portion resulting in slight out of rounded cannulation.No other visual defects were identified.Functional inspection performed using the gage pin as detailed in dimensional review section below showed issues with relevant gage pins passing through the device cannulation.With the relevant gage pins, replication of the actual complaint condition was performed, and with the observed deformation on the distal cannulation end and the functional issue noted the complaint condition was confirmed.Document specification review: distal inner cannulation for drill sleeve: accepted gage pin of max diameter of 7.94 mm which is out of sleeve¿s specification of 8.1 mm + 0.05/-0.However, the observed out of specification is due to the significant post manufacture damage.Proximal inner cannulation for drill sleeve: accepted gage pin of max diameter of 8.50 mm which is within sleeve¿s specification of 8.5 mm +/- 0.05.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to complaint condition.A definitive root cause could not be determined based on the provided information.Conclusion: the overall complaint condition was confirmed.However, no product design issues or manufacturing discrepancies were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 an unknown date, one (1) protection sleeve and one (1) drill sleeve were jammed together.It was unable to be used in the operating room setting.There was no interaction with the patient and no procedure involved.This report is for one (1) 12.0mm/8.0mm protection sleeve 188mm.This is report 1 of 1 for (b)(4).

• Brand Name: 12.0MM/8.0MM PROTECTION SLEEVE 188MM
• Type of Device: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8202904
• MDR Text Key: 131714822
• Report Number: 2939274-2018-55626
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886982067371
• UDI-Public: (01)10886982067371
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/27/2018

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.063
• Device Lot Number: 4818407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2018
• Initial Date FDA Received: 12/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2005
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1