MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC REDUCTION FORCEPS WITH SERRATED JAW-SPEED LOCK 132MM

Model Number 399.79

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 05/28/2019

Event Type  Injury  

Manufacturer Narrative

Part returned.Occupation: j&j field sales enable.(b)(4).The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.A review of the device history record 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 that on (b)(6) 2019, the reduction forceps was used in a case were the clamp on a spend down would not come undone.The clamp had to be clip the part with a rod cutter but the reduction forceps was broken.First, dr clark grabbed a set of pliers to try and loosen the nut on the clamp, but it would not loosen.Next, he requested a large rod cutter in order to cut the clamp loose.He was able to do this successfully, and i was able to collect the broken clamp after the case and have it cleaned.When clamp was cut with rod cutter, only one fragment was produced, and it was collected immediately after clamp was removed there was a surgical delay of 5 minutes and patient outcome was successful.This complaint involves (1) device.This report is 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.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

07/22/2019: updated event description: it was reported that on (b)(6) 2019, the reduction forceps was used to reduce a distal radius fracture were the clamp on a spend down would not come undone.The clamp had to be clip the part with a rod cutter but the reduction forceps was broken.Dr clark then decided to remove clamp, in which the clamp would not release or loosen.To complete the procedure, dr clark first grabbed a set of pliers to try and loosen the nut on the clamp, but it would not loosen.Next, he requested a large rod cutter to cut the clamp loose.He was able to do this successfully.When clamp was cut with rod cutter, only one fragment was produced from broken device, and it was collected easily and immediately after clamp was removed.The broken clamp was collected and cleaned after the case.There was a surgical delay of 5 minutes.Patient outcome was successful.Procedure was successfully completed.This complaint involves (1) device.Unk - cutting instruments: rod cutter tr.

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.Updated event description: it was reported that on (b)(6) 2019, the reduction forceps was used in a case were the clamp on a spend down would not come undone.The clamp had to be clip the part with a rod cutter but the reduction forceps was broken.First, dr clark grabbed a set of pliers to try and loosen the nut on the clamp, but it would not loosen.Next, he requested a large rod cutter in order to cut the clamp loose.He was able to do this successfully, and i was able to collect the broken clamp after the case and have it cleaned.When clamp was cut with rod cutter, only one fragment was produced, and it was collected immediately after clamp was removed there was a surgical delay of 5 minutes and patient outcome was successful.This complaint involves (1) device.Service and repair evaluation: the device was initially received at the service and repair department.The customer reported that the reduction forceps was used in a case were the clamp on a spend down would not come undone.The clamp had to be clip the part with a rod cutter but the reduction forceps was broken.The repair technician reported that jaw is broken, and pieces are missing.Damaged component is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.Investigation flow: functional/damage visual inspection: the reduction forceps with serrated jaw-speed lock 132mm (p/n 399.790 lot 5004939) was received with one of the jaw tips broken off.The broken off fragment was not returned and is missing.No other issues were identified with the returned components of the device.Functional inspection functional testing was performed by opening/closing the forceps and tightening/loosening the nut.No functional issues were observed as the instrument was able to function as intended.The reported complaint condition of the nut not loosening could not be replicated as the device was able to function as intended.The device failure/defect of broken jaw tip was identified during the investigation and is related to the reported complaint condition.Document/specification review: the following drawings, reflecting the current revision, were reviewed since the exact manufacturing date of the instrument is unknown.Reduction forceps se_558890 rev d, regulierspindel/adjusting screw se_548628 rev a.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Conclusion: the complaint condition is confirmed for the reduction forceps with serrated jaw-speed lock 132mm (p/n 399.790 lot 5004939) as one of the jaw tips were broken off.However, functional testing showed that there were no issues with the adjusting screw/nut and spindle.Service and repair reported that the jaw was broken and the broken off piece was missing.While no definitive root cause could be determined for the nut not loosening, it is possible that the nut and spindle were cross threaded, over tightened, or other surgical settings were interfering with the nut at the time of surgery.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 due to the age of more than 10 years of the complained device a wear or use related root cause is the most likely reason of the complained malfunction broken.Per franchise complaint product investigation procedure 100673626, a manufacturing record evaluation is not required for complaint devices where a non-manufacturing related probable cause has been identified.Date of report : changed awareness date from 5/29/2019 to 5/28/2019.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

07/18/2019: updated event description: it was reported that on (b)(6) 2019, the reduction forceps was used to reduce a distal radius fracture were the clamp on a spend down would not come undone.The clamp had to be clip the part with a rod cutter but the reduction forceps was broken.Dr clark then decided to remove clamp, in which the clamp would not release or loosen.To complete the procedure, dr clark first grabbed a set of pliers to try and loosen the nut on the clamp, but it would not loosen.Next, he requested a large rod cutter to cut the clamp loose.He was able to do this successfully.When clamp was cut with rod cutter, only one fragment was produced from broken device, and it was collected easily and immediately after clamp was removed.The broken clamp was collected and cleaned after the case.There was a surgical delay of 5 minutes.Patient outcome was successful.Procedure was successfully completed.This complaint involves (1) device.

• Brand Name: REDUCTION FORCEPS WITH SERRATED JAW-SPEED LOCK 132MM
• Type of Device: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8737414
• MDR Text Key: 149333109
• Report Number: 2939274-2019-58876
• Device Sequence Number: 1
• Product Code: HTD
• UDI-Device Identifier: 10886982203076
• UDI-Public: (01)10886982203076
• 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,Followup
• Report Date: 05/29/2019

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: 399.79
• Device Catalogue Number: 399.79
• Device Lot Number: 5004939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2019
• Initial Date Manufacturer Received: 05/29/2019
• Initial Date FDA Received: 06/26/2019
• Supplement Dates Manufacturer Received: 07/17/2019; 07/22/2019
• Supplement Dates FDA Received: 07/18/2019; 07/23/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR