MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC EXTRACTION BOLT FOR 2.7MM SCREWS; EXTRACTOR

Catalog Number 309.290

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Initial reporter is synthes sales consultant.The device was received, and the product evaluation is in progress.No conclusion can be drawn.Additionally, device history records review has been requested.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 on an unknown date, a cannulated screw partially threaded broke upon insertion into the bone.It is unknown if there was a surgical delay.It is unknown if the procedure was completed successfully.No patient consequence.Device was received by manufacturer with three extraction bolts that were used to remove the broken cannulated screw and may have fragments of the screw in them.This report is for one (1) extraction bolt.This report is 2 of 4 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.Device history records review was completed for part: 309.290, lot: 2804557.Manufacturing location: (b)(4), release to warehouse date: dec 02, 2011.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacturing process.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Product investigation was completed.Visual inspection: the extraction bolt was received with a piece of the screw stuck in the extraction bolt.Functional test: there is a broken piece of a cannulated screw that is stuck in the extraction bolt.The screw cannot be removed.The complaint was not able to be replicated, therefore the complaint is not confirmed.Dimensional inspection: dimensional analysis was not performed as relevant features are blocked and not able to be measured since there is a screw stuck in the extraction portion of the extraction bolt.Relevant drawings were reviewed.Conclusion: the complaint condition is confirmed as the extraction bolt was received with a broken piece of a screw that is stuck in the extraction bolt.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces.No new malfunctions were observed during the course of this investigation.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.

• Brand Name: EXTRACTION BOLT FOR 2.7MM SCREWS
• Type of Device: EXTRACTOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8180189
• MDR Text Key: 130898058
• Report Number: 2939274-2018-55467
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10886982185716
• UDI-Public: (01)10886982185716
• 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: 10/26/2018

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 309.290
• Device Lot Number: 2804557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2018
• Initial Date Manufacturer Received: 11/15/2018
• Initial Date FDA Received: 12/19/2018
• Supplement Dates Manufacturer Received: 12/20/2018
• Supplement Dates FDA Received: 12/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1