MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPREADER 8 BLD MED HNDL-SOFT RATCHET; FORCEPS

Model Number 399.097

Device Problems Device-Device Incompatibility (2919); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Reporter is a j&j representative.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 on an unknown date, during a routine inspection it was found out that the ratchet on a bone-spread softlo w/8 l220 would no longer hold.There was no patient involvement.This complaint involves (1) device.This report is for (1) unk, screws: distal femur.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6- the customer reported the bone-spread softlo w/8 l220 went cold and worn out.The repair technician reported the locking bar worn out, do not have components to repair and unable to unscrew screw.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.The complaint condition is confirmed for the spreader 8 bld med hndl-soft ratchet (part #: 399.097 and lot #: 5903442).There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot
=
> part # 399.097.Lot # 5903442.Manufacturing site: selzach.Release to warehouse date: 21sep2009.Supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot 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: SPREADER 8 BLD MED HNDL-SOFT RATCHET
• Type of Device: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12339510
• MDR Text Key: 267171719
• Report Number: 2939274-2021-04720
• Device Sequence Number: 1
• Product Code: HTD
• UDI-Device Identifier: 10886982202338
• UDI-Public: (01)10886982202338
• 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: 07/20/2021

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: 399.097
• Device Catalogue Number: 399.097
• Device Lot Number: 5903442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2021
• Initial Date Manufacturer Received: 07/20/2021
• Initial Date FDA Received: 08/18/2021
• Supplement Dates Manufacturer Received: 08/19/2021
• Supplement Dates FDA Received: 09/15/2021
• Patient Sequence Number: 1