MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HELICAL BLADE INSERTER; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 03.037.024

Device Problem Device-Device Incompatibility (2919)

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

Event Type  malfunction  

Manufacturer Narrative

The subject 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 Description

It was reported that, during an audit the helical blade inserter was discovered damaged.The helical blade inserter was not smoothly accepting the coupling screw that goes inside of the device, while threading it in order to connect the tfna helical blade.Concomitant device reported: unk - insertion instruments: connecting/coupling screw: trauma (part# unknown; lot# unknown; quantity: 1).This report is for one (1) helical blade inserter.This is report 1 of 1 for complaint (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.Investigation summary visual inspection: the helical blade inserter (p/n: 03.037.024, lot number: t145412) was received at us cq.Visual inspection of the complaint device showed the epoxy markings were missing.No other damage was observed.Functional test: a functional assessment was unable to be performed on the complaint device due to lack of mating devices.The complaint was not able to be replicated.Dimensional inspection: a dimensional inspection was not performed since it was not applicable to the complaint condition and no damage was observed.Document/specification review: no design issues or discrepancies were identified.Complaint confirmed? no.Investigation conclusion: this complaint is not confirmed as a functional test could not be performed.However, the epoxy color markings were missing.However, the red and yellow epoxy markings are missing.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.The missing epoxy was investigated under capa.No product design or manufacturing issues were identified, and no new malfunctions were identified either.Based upon these results, no new 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 history lot: part number: 03.037.024, lot number: t145412, manufacturing site: tuttlingen, release to warehouse date: 22-may-2017.A review of the device history records was performed for the finished device lot number and a nonconformance review was started because the parts were not checked in the final inspection of the finished article but were checked and documented in the work order of the subcomponent.The necessary actions to ensure the final product quality have been taken and documented in the appropriate quality system.The nc have no impact to the complaint condition.The final quality release criteria were met before this batch was released for distribution.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: HELICAL BLADE INSERTER
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12935147
• MDR Text Key: 281759139
• Report Number: 2939274-2021-06964
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982070401
• UDI-Public: (01)10886982070401
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.037.024
• Device Catalogue Number: 03.037.024
• Device Lot Number: T145412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1