MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MOD ALIF SPREADER INSTR ASSY; MISC ORTHO SURGICAL INSTR

Catalog Number	698332308
Medical Device Problem Codes	Device-Device Incompatibility (2919); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a j&j sales representative.A product investigation was conducted.Visual inspection: the mod alif spreader instr assy (p/n: 698332308, lot number: g0310) was received at us cq.Visual inspection of the complaint device showed no exterior damage to the device.Functional test: a functional assessment was performed on the complaint device with the returned mating tips.All of the returned tips were able to insert, lock, and be removed from the device without any issues.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.Document/specification review: relevant drawings were reviewed.No design issues or discrepancies were identified.Investigation conclusion: this complaint is not confirmed as no damage was observed and the returned tips passed the functional test.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.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 device history record (dhr) review was conducted: part # 698332308.Lot # g0310.Supplier: (b)(4).Batch # 1 qty (b)(4).Release to warehouse date: 14 apr 2010.No ncr's 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.
Event or Problem Description
It was reported on an unknown date, the custom t-handle alif spreader tolerance seems out of spec and the individual spreader tips are sticking inside the t-handle.There was no patient consequence.Procedure outcome is unknown.This report is for one (1) mod alif spreader instr assy.This is report 1 of 1 for complaint (b)(4).

• Brand Name: MOD ALIF SPREADER INSTR ASSY
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 11605384
• Report Number: 1526439-2021-00612
• Device Sequence Number: 19885168
• Product Code: LXH
• UDI-Device Identifier: 10705034232690
• UDI-Public: (01)10705034232690
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/24/2020

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 Catalogue Number: 698332308
• Device Lot Number: G0310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 04/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1