MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICROQA+ W/#4OC P3; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number	212042
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Not Applicable (3189)
Date of Event	01/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).The expiration date is unknown.
Event or Problem Description
It was reported by the affiliate via cst tool that during an extensor tenolysis, ifp capsulotomy, insertion tenorrafia of the extensor of the fifth finger of the right hand the microqa+'s orthocord suture with needle broke.The orthocord suture strands were removed from the patient and a different suture was used to repair the tendon.The surgery was performed successfully without any patient consequences, but a 15 minutes delay.However, the titanium anchor was left inside the patient.The anchor did not fulfill it's function and remained within the bone without causing any affectation to the patient and the surgeon states that it is not necessary to remove it.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the complaint device was received and inspected.The complaint can be confirmed.The suture was observed to be cut in half.The inserter of the device was inspected for any gross visual defects that may contribute to the complaint condition, however none we observed.It is possible that the bone surrounding the insertion site of the implant was rough.Per the ifu, if the bone surrounding the insertion site is rough, the sutures can become damaged if they come in contact with the rough bone during insertion therefore is a potential root cause for the suture breakage experienced by the customer.However, given the information provided we cannot discern a definitive root cause for the reported failure.A non-conformance search was conducted to investigate any defects identified during production that may contribute to the complaint condition.No non-conformance was identified for this part-lot number combination.At this point, 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).The expiration date is unknown.

• Brand Name: MICROQA+ W/#4OC P3
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8326391
• Report Number: 1221934-2019-56378
• Device Sequence Number: 13900492
• Product Code: HWC
• UDI-Device Identifier: 10886705001880
• UDI-Public: 10886705001880
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K080352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 212042
• Device Lot Number: L768019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2019
• Initial Date Received by Manufacturer: 01/22/2019
• Supplement Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 02/11/2019
• Supplement Report FDA Received Date: 04/11/2019
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Weight: 79