MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC REDUCTION JOYSTICK/5.0MM; FORCEPS

Model Number 03.211.454

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 09/03/2019

Event Type  Injury  

Manufacturer Narrative

Additional procode is lxh.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.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.(b)(4).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) 2019 during an open reduction internal fixation (orif) of a calcaneus fracture that the distal threaded end of a 5mm reduction joystick snapped as it was being pulled to get a reduction of the calcaneus.It snapped where the compression nut contacts the bone.The broken end was retrieved from the bone and the procedure was completed successfully with a 6.5mm reduction joystick.The patient outcome is unknown.This report is for one (1) reduction joystick/5.0mm.This is report 1 of 1 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.Background: it was reported that on (b)(6) 2019, during an open reduction internal fixation (orif) of a calcaneus fracture, as the surgeon was using the 5mm reduction joystick as he was pulling on it to get a reduction of the calcaneus, the distal threaded end snapped where the compression nut contacts the bone and used broken screw removal set to retrieve the broken end in the patient¿s bone then used the bigger, 6.5mm reduction joystick to attain reduction.It is unknown if there was a surgical delay.Procedure successfully completed.Patient outcome is unknown.This complaint involves one (1) device.Investigation flow: damage visual inspection: the reduction joystick/5.0mm (p/n 03.211.454 lot h786283) was received at customer quality, and it was observed that the device was broken into two pieces along the threaded shaft.Both pieces were returned to us cq.The device was missing 1.6mm centering pin.The complaint is confirmed.Device failure/ defect identified? yes, the device was broken into two pieces along the threaded shaft.Dimensional inspection: the minor thread diameter ø 3.5 +0.05/- 0.10mm of the shaft got measured.Drawing: threaded shaft for 5.0mm reduction joystick, 03_211_454_1 rev f, minor thread diameter: ø 3.5 +0.05/- 0.10mm, caliper: ca 215p, measured diameter = ø 3.54 mm , conclusion: the measuring result does show conformity.Document/ specification review: the manufacturing record evaluation was found to not impact the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Investigation conclusion: a definitive assignable root cause for the post manufacturing damage could not be determined based on the provided information.This complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique or different patient harms were identified because of this evaluation.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.A review of the device history record has been requested.Device history lot manufacturing location: supplier - (b)(4), packaged and released by: monument release to warehouse date: 21-jun-2019, part number: 03.211.454 reduction joystick/5.0mm, lot number: h786283 (non-sterile), lot quantity: 100.Purchased finished goods traveler met all inspection acceptance criteria.Certificate of compliance supplied by avalign dated 21-may-2019 was reviewed and determined to be conforming.Note: individual material types are identified on the certificate, but lot/heat numbers are not notated.Hardness specified at hrc 50-55 and was certified at 51 hrc.Inspection sheet, incoming final inspection, ns069273 rev d met all inspection acceptance criteria.Packaging label log (pll) lppf rev c, lmd rev a was reviewed and determined to be conforming.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.Device history batch null, device history review 08-oct-2019: this lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.Lot number provided for reporting.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: REDUCTION JOYSTICK/5.0MM
• Type of Device: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9129859
• MDR Text Key: 163767904
• Report Number: 2939274-2019-60961
• Device Sequence Number: 1
• Product Code: HTD
• UDI-Device Identifier: 10886982076465
• UDI-Public: (01)10886982076465
• 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,health
• Type of Report: Initial,Followup
• Report Date: 09/03/2019

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
• Device Operator: Health Professional
• Device Model Number: 03.211.454
• Device Catalogue Number: 03.211.454
• Device Lot Number: H786283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Initial Date Manufacturer Received: 09/03/2019
• Initial Date FDA Received: 09/27/2019
• Supplement Dates Manufacturer Received: 10/02/2019
• Supplement Dates FDA Received: 10/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention