MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.0MM VAL STRAIGHT PLATE 12 HOLES; PLATE, FIXATION, BONE

Model Number 02.130.351

Device Problem Material Deformation (2976)

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

Event Type  malfunction  

Manufacturer Narrative

Without a lot number the device history records review could not be completed.Product was not returned.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.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) 2021, a 12 hole plate was discovered as bent.No patient was involved.This report is for one (1) 2.0mm val straight plate 12 holes 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: visual inspection: the 2.0mm val straight plate 12 holes (p/n: 02.130.351, lot number: unk) was received at us customer quality (cq).Visual inspection of the received device showed the plate was bent.No other issues were identified with the returned device.Device failure/defect identified? yes.Dimensional inspection: specified dimensions: thickness of the plate measured dimensions: thickness of the plate = conforming.Document/specification review: since the exact manufactured date of the device was not identified, the current revision of drawings was reviewed va-locking plate 2.0, straight no design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the plate was bent.While a definitive root cause could not be identified, it is possible that an unintended force on the plate could have contributed to the complaint condition.No design issues were observed during the document/specification review.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 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: 2.0MM VAL STRAIGHT PLATE 12 HOLES
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12274166
• MDR Text Key: 264969074
• Report Number: 2939274-2021-04471
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982045331
• UDI-Public: (01)10886982045331
• Combination Product (y/n): N
• PMA/PMN Number: K150099
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/06/2021

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: 02.130.351
• Device Catalogue Number: 02.130.351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2021
• Initial Date Manufacturer Received: 07/06/2021
• Initial Date FDA Received: 08/04/2021
• Supplement Dates Manufacturer Received: 08/19/2021
• Supplement Dates FDA Received: 08/31/2021
• Patient Sequence Number: 1