MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC INSERTER/EXTRACTOR FOR CHILD & ADOLESCENT OSTEOTOMY PLATES

Model Number	332.353
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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 on (b)(6) 2020, it was noticed that both screws in the two (2) inserter/extractor for child hip plate were bound or cross-threaded making them unusable.The sales consultant attempted to unscrew the one in the infant inserter/extractor, but the screw head snapped off.This did not impact a surgery, as the sales consultant was checking the set beforehand.There was no patient involvement.This report involves one (1) inserter/extractor for child & adolescent osteotomy plates.This is report 2 of 2 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h4, h6: part number: 332.353; synthes lot number: 7930179; supplier lot number: n/a; release to warehouse date: 22jun2015; expiration date: n/a; manufactured by synthes jennersville.No ncrs were generated during production.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.Visual inspection: the inserter/extractor for child & adolescent osteotomy plates (p/n: 332.353, lot number: 7930179) was received at us customer quality (cq).Visual inspection of the complaint device showed the bolt components are jammed and could not be loosened.There was no evidence of breakage.Functional test: a functional assessment was performed with the complaint device.The bolt components are jammed and unable to loosen.The condition can be replicated.Dimensional inspection: a dimensional inspection was not performed due to the nature of the complaint condition.Document/specification review: current and manufactured were reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the bolt components are jammed and could not be loosened.There was no evidence of breakage.No root cause could definitively be determined for the reported complaint condition.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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 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: INSERTER/EXTRACTOR FOR CHILD & ADOLESCENT OSTEOTOMY PLATES
• Common Device Name: EXTRACTOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9882469
• Report Number: 2939274-2020-01517
• Device Sequence Number: 2857378
• Product Code: HWB
• UDI-Device Identifier: 10886982192745
• UDI-Public: (01)10886982192745
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2020

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: 332.353
• Device Catalogue Number: 332.353
• Device Lot Number: 7930179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Initial Date Received by Manufacturer: 03/04/2020
• Supplement Date Received by Manufacturer: 04/02/2020
• Initial Report FDA Received Date: 03/26/2020
• Supplement Report FDA Received Date: 04/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1