MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC COMPRESSION/DISTRACTION INSTRUMENT; INSTRUMENT, COMPRESSION

Model Number	03.111.021
Medical Device Problem Codes	Device-Device Incompatibility (2919); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Part: 03.111.021.Lot: t948349.Manufacturing site: (b)(4).Release to warehouse date: october 06, 2010.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the compression/distraction instrument was returned and received at us customer quality (cq).Upon visual inspection, scratches were observed on the device but have no impact on the device functionality.No other issues were observed with the returned device.Functional test: a functional test was performed on the returned device.During the functional test, the sliding arm was not able to rotate as the body retainer component was jammed.Dimensional inspection: a dimensional inspection was not performed as the internal components were inaccessible without destruction of the device.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed.Distractor compact foot: investigation conclusion: the complaint condition was confirmed for the compression/distraction instrument.There is no indication that a design or manufacturing issue has caused the complaint condition 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.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 unknown date, the compression/distraction instrument malfunctioned and was unable to be assembled properly, the hinge was jammed.There was no patient involvement.This report is for a compression/distraction instrument.This is report 1 of 1 for (b)(4).

• Brand Name: COMPRESSION/DISTRACTION INSTRUMENT
• Common Device Name: INSTRUMENT, COMPRESSION
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11555954
• Report Number: 2939274-2021-01489
• Device Sequence Number: 11813139
• Product Code: HWN
• UDI-Device Identifier: 10886982072207
• UDI-Public: (01)10886982072207
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/23/2021

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
• Operator of Device: Health Professional
• Device Model Number: 03.111.021
• Device Catalogue Number: 03.111.021
• Device Lot Number: T948349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 03/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1