MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - WASHERS; BOLT, NUT, WASHER

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

Patient Problems Tissue Damage (2104); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for unknown washers/unknown lot.Part and lot number are unknown; udi number is unknown.Date of implantation is an unknown date between 1992 and 1996.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(b)(4).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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: ranebo m., björnsson hallgren h., norlin r., adolfsson (2018), long-term clinical and radiographic outcome of rotator cuff repair with a synthetic interposition graft: a consecutive case series with 17 to 20 years of follow-up, journal of shoulder and elbow surgery volume 27 (9), pages 1622- 1628 (sweden).This study aims to retrospectively investigate the clinical and radiologic results 17 to 20 years after a bridging rotator cuff repair with a dacron graft and specifically whether these operations had prevented cuff tear arthropathy.Between 1992 and 1996, a consecutive series of 13 patients (11 men and 2 women), with a mean age of 55 years (range, 38-72 years) at the time of surgery, underwent operations with a dacron patch to cover the defect of an irreparable rotator cuff tear were included in the study.An appropriately sized dacron graft was used and sutured to the remaining edge of the tendon medially and fixed to bone laterally with a fully threaded 6.5-mm cancellous screw with a washer (synthes, zuchwil, switzerland).Follow-up was done after a mean of 18 years (range, 17-20 years).The following complications were reported: at follow-up after a mean of 18 years (range, 17-20 years), 1 patient had died.In the shoulders repaired with a graft, cuff tear arthropathy had developed in 9 of 12 patients.Patient 1: a case of a (b)(6) year-old male underwent hemiarthroplasty at another hospital 13 years after the index operation.Patient 4: a case of a (b)(6) year-old male patient had a transient fever but no verified infection.The patient was classified as hamada 1, had signs of osteoarthritis but no decrease of the acromiohumeral interval.Patient 6: a case of a (b)(6) year-old male patient had a transient fever but no verified infection.Patient 8: a case of a (b)(6) year-old male patient had a transient fever, received antibiotics but wound cultures were negative, and infection could not be verified.The patient also underwent anatomic total shoulder replacement 2 years after the index operation, where the dacron graft was found not to be in continuity with remnants of the cuff.Patient 9: a case of a (b)(6) year-old male received a reverse prosthesis at another hospital 16 years after the index operation.According to medical records from this arthroplasty procedure, remnants of the torn dacron graft was removed, and there was an infraspinatus tear.Patient 13: a case of a (b)(6) year-old male patient had a transient fever, received antibiotics but wound cultures were negative, and infection could not be verified.A loose screw was later removed, and perioperative cultures from this procedure were negative.This report is for an unknown synthes 6.5-mm cancellous screw with a washer.This is report 2 of 4 for (b)(4).Additional reports are captured under (b)(4).

• Brand Name: UNK - WASHERS
• Type of Device: BOLT, NUT, WASHER
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9510620
• MDR Text Key: 188659246
• Report Number: 8030965-2019-71349
• Device Sequence Number: 1
• Product Code: HTN
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention