MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HOOK OR SCREW HOLDER; MISC ORTHO SURGICAL INSTR

Model Number	388.61
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the surgeon mentioned the last time the universal spinal system (uss) were used, the following instruments were not functioning.Upon inspection it is clear that the two (2) handle for hook/screw holder don't hold the sticks, eight (8) sticks/hook are bent, and two (2) persuaders/rod introduction pliers aren't reducing properly, one (1) bend template for rod unspecified malfunction, and two (2) socket wrench with straight handle unspecified malfunction.There was no patient involvement.This complaint (b)(4) captures 2 devices and complaint (b)(4) captures 13 devices.This is report 1 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- the hook or screw holder (p/n 388.61) was received with the following components: outer sleeve (p/n 388.61.02 lot a4gl034); stem (p/n 388.61.001 lot 1025); the tabs on the outer sleeve are bent/warped and worn and scratches were observed on the sleeve.The outer sleeve showed potential end of life indicator of bent/warped feature for the connector/engagement tabs and scratched from normal wear.The distal threads on the stem were observed to be stripped, showing potential end of life indicator of stripped threads from normal wear after a visual inspection it is determined that the reusable instrument is worn from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: p/n 388.61.001; lot 1025.Dhr not available as device is older than 23 years.At this time the manufacturing documents for instruments had to be stored for 10 years.P/n 388.61.02.Lot a4gl034.Due to the age of more than 10 years of the complained device a wear or use related root cause is the most likely reason of the complained malfunction.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.
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.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: HOOK OR SCREW HOLDER
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8717512
• Report Number: 2939274-2019-58781
• Device Sequence Number: 2003598
• Product Code: LXH
• UDI-Device Identifier: 10705034773612
• UDI-Public: (01)10705034773612
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/24/2019

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: 388.61
• Device Catalogue Number: 388.61
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• Initial Date Received by Manufacturer: 05/24/2019
• Supplement Date Received by Manufacturer: 08/16/2019; 08/20/2019
• Initial Report FDA Received Date: 06/20/2019
• Supplement Report FDA Received Date: 08/16/2019; 08/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1