MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL 5.5MM HEALX ADV SP PEEK ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 222425

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem No Patient Involvement (2645)

Event Date 03/16/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint#: (b)(4).Investigation summary: complaint description: it was reported by sales rep via email that during a rotator cuff repair, it was noticed that a 5.5mm healx adv sp peek anchor, was missing the anchor, this was discovered before the device was used so they opened another one to complete procedure.No surgical delay, or patient consequence reported.Investigation summary: the device was received in opened condition without original packaging at cq.Upon visual inspection, it was noticed that the anchor was missing.However complaint of upon receipt: missing component can not be confirmed since the device was received in open condition without original packaging.A manufacturing record evaluation was done by cyril: mre has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.The results show that this batch of product was processed without any incident.Nevertheless, there is no evidence of manufacturing anomalies on the paperwork reviewed.There was no non conformance for this batch.Based on given the information provided we cannot discern a definitive root cause for the reported failure.A manufacturing record evaluation was performed for the finished device lot number (5l93067), and no non-conformances related to the reported complaint condition were identified.At this time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field, according to the information provided, it was reported that during a rotator cuff repair, it was noticed that it was missing the anchor, this was discovered before the device was used so they opened another one to complete procedure.The complaint device is not being returned, therefore unavailable for a physical evaluation.However, a photo was provided.Upon visual inspection of the photo, it was identified that the distal part did not have any anchor and the device where out of the box.The photo provide evidence of the missing component however, complaint cannot be confirmed for the upon receipt, missing feature since the device was shown in open condition( not in sealed packaging).As a result, we cannot determine a root cause for the reported failure.Hands on analysis should provide more evidence to be able to discern a root cause.A manufacturing record evaluation was performed for the finished device lot number: 5l93067, and no non-conformances were identified. at this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Udi: (b)(4).

Event Description

It was reported by sales rep via email that during a rotator cuff repair, it was noticed that a 5.5mm healx adv sp peek anchor, was missing the anchor, this was discovered before the device was used so they opened another one to complete procedure.No surgical delay, or patient consequence reported.

• Brand Name: 5.5MM HEALX ADV SP PEEK ANCHOR
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT MITEK; chemin blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 10715233
• MDR Text Key: 212563403
• Report Number: 1221934-2020-03131
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10886705030606
• UDI-Public: 10886705030606
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182941
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 222425
• Device Catalogue Number: 222425
• Device Lot Number: 5L93067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2020
• Date Manufacturer Received: 10/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1