MAUDE Adverse Event Report: ACUMED LLC POLARUS® 3 LOCKING NAIL 200MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT: NAIL

Model Number 4002-10200-S

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

A polarus 3 proximal nail was implanted on (b)(6) 2020.On (b)(6) 2021, it was explanted due to nail loosening and infection.The technique used by the surgeon is thought to be the root cause of the issue.

Manufacturer Narrative

Email communication was received from the field on 24 january 2022 indicating the device model number was actually: 4002-10200-s and batch/lot number is 325224.The complaint record was updated with this information.The device was received for evaluation on 31 january 2022, and the evaluation was completed on 7 february 2022.Manufacturing and inspection records for the updated batch/lot number were reviewed, and no anomalies were found.The returned product was visually inspected under magnification.Polarus 3 locking nail 200mm (pn 4002-10200-s) the locking nail had a batch number confirmed as 325224.The surface of the locking nail showed slight, minimal wear and no signs of major damage.The distal holes showed a yellow substance stuck inside them that is possibly remnants of adipose tissue or other biologic material.The distal most slot showed some denting, scratches and deformation on the surface of the nail, around the edges as well as on the inner surface of the hole.The peek insert at the proximal end of the nail (pn 4003-5834n) was misaligned with the proximal holes and significantly deformed and damaged, particularly at the most proximal end.It is not possible to determine if these signs of damage occurred during implant, use, or explant.Possible reasons for the damage seen in the returned product include damage incurred during the explant procedure or improper following of the surgical technique.Therefore, no definitive conclusion can be made.The issue will continue to be monitored via trending.

• Brand Name: POLARUS® 3 LOCKING NAIL 200MM
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT: NAIL
• Manufacturer (Section D): ACUMED LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer (Section G): ACUMED LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer Contact: micki anderson ; 5885 ne cornelius pass road; hillsboro, OR 97124 ; 5032071387
• MDR Report Key: 12720443
• MDR Text Key: 281340313
• Report Number: 3025141-2021-00119
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K131636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4002-10200-S
• Device Catalogue Number: 4002-10200-S
• Device Lot Number: 325224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2022
• Date Manufacturer Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention