MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PROVISIONAL TENSIONING DEVICE; MISC ORTHO SURGICAL INSTR

Model Number	391.884
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was 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 an unknown date, a provisional tensioning device would not retain- the top doesn¿t stay on, and it appeared that the spring inside had been broken.The issue happened before surgery while assembling the cable system for a case.They opened up a second set.There was no patient involvement.Unknown cable system (part# unknown, lot# unknown, quantity# unknown).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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6 investigation summary visual inspection: the provisional tensioning device (p/n: 391.884, lot # p305309) was returned and received at us cq.Upon visual inspection, it was observed that the coil spring has partially fallen out of its groove and is resting at the base of the counterbore feature which mates to the tensioner.Defect identified? yes dimensional inspection: dimensional inspection was conducted at rti surgical the outer diameter of the groove was passed dimensional inspection as it was within the specification of.250 +.002/-.001 mm per drawing document/specification review drawing was reviewed complaint confirmed? yes, the device received was dislodged.Hence confirming the allegation.Investigation conclusion the complaint condition is confirmed.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.A review of past complaints has determined that this is the 12th occurrence from 01/01/2018 to present, related to canted coil spring disassociating from its spring groove.Based on total depuy synthes units sold, the complaint rate was less than 0.01%.Further investigation will not be performed as the risk-based review of prior occurrence trending and the risk management section of the dhf for this product has concluded that the risk is below the actionable limit and not likely to cause serious injury or death to the patient or user.Device history part number: 391.884 synthes lot number: p305309 supplier lot number: n/a release to warehouse date: 04jun2004 expiration date: n/a supplier: pioneer surgical technology no ncrs were generated during production.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: PROVISIONAL TENSIONING DEVICE
• 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: 9536355
• Report Number: 2939274-2019-62815
• Device Sequence Number: 3603419
• Product Code: LXH
• UDI-Device Identifier: 10886982198365
• UDI-Public: (01)10886982198365
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2019

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: 391.884
• Device Catalogue Number: 391.884
• Device Lot Number: P305309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Initial Date Received by Manufacturer: 12/06/2019
• Supplement Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 12/31/2019
• Supplement Report FDA Received Date: 01/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - TENSIONING INSTRUMENTS