MAUDE Adverse Event Report: BAAT MEDICAL PRODUCTS B.V. ANSER CLAVICLE PIN; ORTHOPEDIC CLAVICLE PIN FIXATION DEVICE

Model Number ANS-301S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Malunion of Bone (4529); Unspecified Musculoskeletal problem (4535)

Event Date 05/25/2022

Event Type  Injury  

Event Description

A surgeon, (b)(6), that uses the anser reported feedback regarding an event that occurred.The anser was placed in the usa.The adverse even occurred in a female patient of mid-sixties.He saw a patient again after placing anser.2.5 weeks old with protrusion of the pin but medially through the medial part of the clavicle.No other complications except hardware irritation occurred.The initial reduction appeared almost anatomical but secondary shortening nevertheless occurred.According to the surgeon the fractured clavicula did shorten after the operation, probably due to poor bone quality.As a result the implant protruded through the bone at the medial side (near the sternum) which caused hardware irritation.Protrusion was at the anterior side of the clavicle.The surgeon uncomplicatedly removed during a second operation the hardware successfully.

Manufacturer Narrative

In case of such a protrusion, it will always occur at the anterior side (so outwards) because the implant is elastically bended during insertion and therefore always has the tendency to straighten.The location of protrusion is the same as the entry point for the ten nail, the predicate device for this implant.Protrusion of the ten nail at this location is a known complication.Protrusion at this side does not initiate serious risk for the patient except hardware irritation as there are no vital structures around this area that could be damaged.

• Brand Name: ANSER CLAVICLE PIN
• Type of Device: ORTHOPEDIC CLAVICLE PIN FIXATION DEVICE
• Manufacturer (Section D): BAAT MEDICAL PRODUCTS B.V.; f. hazemeijerstraat 800; hengelo, overijssel 7555 RJ; NL 7555 RJ
• Manufacturer (Section G): BAAT MEDICAL PRODUCTS B.V.; f. hazemeijerstraat 800; hengelo, overijssel 7555 RJ; NL 7555 RJ
• Manufacturer Contact: jasper springer ; f. hazemeijerstraat; hengelo, overijssel 7555 -RJ ; NL 7555 RJ
• MDR Report Key: 14941789
• MDR Text Key: 295404925
• Report Number: 3015216945-2022-00001
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 08719425460727
• UDI-Public: (01)08719425460727(17)230125(10)21-00003
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201830
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2023
• Device Model Number: ANS-301S
• Device Catalogue Number: ANS-301S
• Device Lot Number: 21-00003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2021
• 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
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian