MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC REDUCTION FORCEPS WITH POINTS NARROW-RATCHET

Model Number	SD398.400
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: the device has been 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 or Problem Description
It was reported that on (b)(6) 2020, the clamp was placed on fracture in attempt to reduce it.The clamp tooth broke while ratcheting the clamp.The clamp was removed.There were no fragments generated from the broken device.There was no surgical delay reported.The procedure was successfully completed.There was no patient consequence.This report involves one (1) reduction forceps with points narrow-ratchet.This is report 1 of 1 for (b)(4).
Additional 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.H10 additional narrative: h3, h6: a product investigation was conducted: investigation flow: damage.Visual inspection: the reduction forceps with points narrow-ratchet (part #: sd398.400, lot #: h231834) was returned and received at us cq.Upon visual inspection, it was observed that one of the serrated jaws was broken at its distal tip, and the broken fragment was not received at us cq.No other issues were identified with the returned components of the device.Device failure/defect identified? yes.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Document/specification review the current and manufactured drawings were reviewed.Complaint confirmed? yes, the device received is broken.Hence confirming the allegation.Investigation conclusion the complaint condition is confirmed for the reduction forceps with points narrow-ratchet (part #: sd398.400, lot #: h231834).There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.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.H3, h4, h6: a device history record (dhr) review was conducted: part number: sd398.400.Synthes lot number: h231834.Supplier lot number: n/a.Release to warehouse date:(b)(6) 2017 expiration date: n/a.Manufactured by synthes(b)(6).No ncrs were generated during production.Device history review 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.

• Brand Name: REDUCTION FORCEPS WITH POINTS NARROW-RATCHET
• Common Device Name: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10199697
• Report Number: 2939274-2020-02982
• Device Sequence Number: 1071662
• Product Code: HTD
• UDI-Device Identifier: 10886982269577
• UDI-Public: (01)10886982269577
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2020

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
• Operator of Device: Health Professional
• Device Model Number: SD398.400
• Device Catalogue Number: SD398.400
• Device Lot Number: H231834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• Initial Date Received by Manufacturer: 06/15/2020
• Supplement Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 06/26/2020
• Supplement Report FDA Received Date: 07/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1