MAUDE Adverse Event Report: ZIMMER SURGICAL PAVLIK HARNESS, SMALL

Catalog Number 00-1716-010-00

Device Problems Bent (1059); Break (1069); Product Quality Problem (1506)

Patient Problem Injury (2348)

Event Date 06/01/2014

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.A review of the device history record (dhr) for lot 24503 noted no relevant issues.Two samples each from current inventory of the 00-1716-010-00 small harness and the 00-1716-011-00 medium harness were evaluated.The buckles were reviewed and compared to the approved sample and no issues were noted.The customer's reported event of poor buckle quality cannot be confirmed.The devices were not returned for analysis.The review of the manufacturing process, dhr and specifications do not indicate any systemic issues.The conditions of the devices or the original shipping containers are unknown.Additionally, the storage conditions and handling process is unknown.Speculating, the most likely cause for the buckles breaking is handling or in transit damage.

Event Description

It was initially reported that the buckle on the harness broke and could have seriously hurt the baby.Another device was then checked was also found to be of a very poor standard.Additional clinical information clarified that the baby was put into a harness in (b)(6) 2014 at (b)(6) of age and the problem of the buckle bending out of shape was noted within the first 4 weeks.The buckle got caught in the cellular blanket - when the parent went to lift the baby up, the buckle was pulled out of shape by the traction force of the blanket.The harness was replaced the following day and the baby was placed in a size small pavlik harness and all the buckles were taped down to prevent any distortion.When the tape was removed from around the buckle, the physiotherapist was stabbed by the spears of the right shoulder strap.Blood droplets fell onto and soiled the harness and it had to be removed from the baby.No further issues occurred with the replacement harness.Additional clarification received on 9/7/15 indicated that the issue occurred when the metal capping system that covers the sharp end of the spears at the buckle of the right shoulder strap.The spears had penetrated through the material of the strap, lay exposed to the skin of the child's thorax and the physiotherapist received a stab wound to the left middle finger.There was no injury to the baby reported.There was no medical treatment/intervention given to the physiotherapist.It was stated that the incident was not reported to infection control as the wound was not considered a needle stick or sharps injury and the physiotherapist stated that her tetanus and hepatitis b vaccinations were both up to date.

• Brand Name: PAVLIK HARNESS, SMALL
• Type of Device: PAVLIK HARNESS, SMALL
• Manufacturer (Section D): ZIMMER SURGICAL; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: jennifer hutchison ; 200 west ohio avenue; dover, OH 44622 ; 3303438801
• MDR Report Key: 5135852
• MDR Text Key: 28248255
• Report Number: 1526350-2015-00172
• Device Sequence Number: 1
• Product Code: IOZ
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 09/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00-1716-010-00
• Device Lot Number: 24503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1